STANDARD
OPERATING
PROCEDURES FOR
GOOD CLINICAL
PRACTICE AT THE
INVESTIGATIVE SITE
A PUBLICATION OF THE CENTER FOR CLINICAL RESEARCH PRACTICE, INC.
ISBN: 1-931107-55-6
Copyright © 1998, 2001, 2003 by the Center for Clinical Research Practice, Inc. All rights
reserved. This document and accompanying software may not, in whole or in part, be copied,
photocopied, reproduced, translated or reduced in any form or manner including by any
electronic, digital, or mechanical means to any medium, electronic or otherwise, or machine
readable form including any information storage, scanning, or retrieval system without the prior,
express written consent from the Center for Clinical Research Practice, Inc.
Date of version: 12/29/2010
Replaces previous version: 07/01/2009
Approved by: ________________________________
GA - 102
STANDARD OPERATING PROCEDURE FOR
RESPONSIBILITIES OF THE RESEARCH TEAM
1. INTRODUCTION AND PURPOSE
The principal investigator (PI) is the individual of record who assumes the authority and
responsibility for the conduct of a clinical study. By signing Form FDA 1572, the PI
agrees to comply with the conditions required by FDA for use of investigational articles.
The PI has the authority to delegate responsibility to individual members of the research
team; however, the PI is ultimately responsible for the overall conduct of the study.
2. SCOPE
This standard operating procedure (SOP) defines the responsibilities of the research
team for conducting clinical studies at this investigative site. It identifies administrative
accountability as well as general responsibilities of the research team and of individual
team members for fulfilling regulatory and clinical requirements.
3. APPLICABLE REGULATIONS AND GUIDELINES
21 CFR 312.53
21 CFR 312.60
21 CFR 312.61
21 CFR 312.62
21 CFR 312.64
21 CFR 312.66
21 CFR 312.68
21 CFR 312.69
21 CFR 54
January 1988
FDA Information
Sheets October
1998
May 1997
Selecting investigators and monitors
General responsibilities of investigators
Control of the investigational drug
Investigator recordkeeping and record retention
Investigator reports
Assurance of IRB review
Inspection of investigator's records and reports
Handling of controlled substances
Financial Disclosure by Clinical Investigators
Guidelines for the Monitoring of Clinical
Investigations
Frequently Asked Questions, Continuing Review
After Study Approval, Recruiting Study Subjects,
Payment to Research Subjects, Screening Tests
Prior to Study Enrollment, A Guide to Informed
Consent, Sponsor-Investigator-IRB Interrelationship
International Conference on Harmonisation; Good
Clinical Practice: Consolidated Guideline
1
GA-102, Responsibilities of Research Team
Date of version: 12/29/2010
Replaces previous version: 07/01/2009
4. REFERENCES TO OTHER APPLICABLE SOPs
All SOPs are applicable to this SOP.
5. ATTACHMENTS
A.
B.
C.
D.
E.
F.
G.
H.
Form FDA 1572
Saint Mary’s Health Care Financial Disclosure Form
Form FDA 3455
Delegation of Responsibility Form
Principal Investigator Roles & Responsibilities
Clinical Research Coordinator Job Description
Data / Finance Analyst Job Description
Clinical Research Assistant Job Description
6. RESPONSIBILITY
This SOP applies to those members of the clinical research team involved in
supervising, managing, or conducting study-related activities. This includes the
following:





Principal investigator
Sub-investigator
Clinical Research Coordinator
Director, Research & Innovation
Data / Finance Analyst
7. DEFINITIONS
The following definitions from the International Conference on Harmonisation, Good
Clinical Practice: Consolidated Guideline apply to this SOP.
Clinical trial/study: Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism, and excretion of an investigational
product(s) with the object of ascertaining its safety and/or efficacy.
Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a
trial is conducted by a team of individuals at a trial site, the investigator is the
responsible leader of the team and may be called the principal investigator.
Sub-investigator: Any individual member of the clinical trial team designated and
supervised by the investigator at a trial site to perform critical trial-related procedures
and/or to make important trial-related decisions (e.g., associates, residents, research
fellows).
2
GA-102, Responsibilities of Research Team
Date of version: 12/29/2010
Replaces previous version: 07/01/2009
8. PROCESS OVERVIEW
A. Administrative responsibilities
B. General responsibilities of the research team
C. Individual responsibilities within the research team
9. PROCEDURES
A. Administrative responsibilities




PI
Director, Research &
Innovation
Clinical Research
Coordinator
Data / Finance Analyst
Participate as appropriate in the hiring and training
of individuals recruited as members of the research
team.
The PI assigns in conjunction with the Director,
Research & Innovation trained Clinical Research
Coordinators / Study Coordinators to manage each
clinical study planned or ongoing at this site.
Manages the business aspects of studies, including
developing and negotiating study budgets and
contracts, done in conjunction with the PI.
B. General responsibilities of the research team


PI
Sub-investigator

Clinical Research
Coordinator
Conduct clinical studies according to FDA
regulations and guidelines, the requirements of
applicable law and Saint Mary’s Health Care policies
and procedures and the SOPs of this clinical site.
Ensure that the PI is informed in a timely manner of
all study-related activities.
Ensure the safety and welfare of study subjects by
being knowledgeable about ongoing study protocols
and investigational articles.
All investigators and covered research personnel
must comply with federal regulations governing
disclosure of personal, professional or financial
interests in a research study that may impact upon
its conduct, evaluation or outcome.
3
GA-102, Responsibilities of Research Team
Date of version: 12/29/2010
Replaces previous version: 07/01/2009
C. Individual responsibilities within the research team

PI
Sign Form FDA 1572 to acknowledge
responsibilities as defined by the regulations
(Attachment A, Form FDA 1572).
Provide sponsor with required information that
either:
Attests to the absence of financial interests or
arrangements as described in the regulations (CFR
54.4) and reported on Saint Mary’s Health Care
Financial Disclosure Form and/or sponsor-provided
financial disclosure form.
or
Provides the sponsor a complete and accurate
disclosing of financial interests and arrangements as
described in the regulations (CFR 54.4) and
reported on Form FDA 3455 that is completed by
the sponsor).
While retaining knowledge of and overall authority
for the conduct of all studies, supervise members of
the research team qualified by their education and
training and state and local laws to accept these
responsibilities for study-related activities not
directly performed by the PI.
Document the delegation of responsibilities
(Attachment D, Delegation of Responsibility Form).
Ensure the safety and welfare of study subjects by
being knowledgeable about ongoing study protocols
and investigational articles.
Participate as appropriate in the hiring and training
of individuals recruited as members of the research
team.
Assign in conjunction with the Director of Research
& Innovation trained Clinical Research Coordinators
/ Study Coordinators to manage each clinical study
planned or ongoing at this site.
Ensure that specific sponsor requirements of the PI
are fulfilled as requested.
Meet with sponsors’ representatives as appropriate
to discuss planned and ongoing studies.
Meet with auditors (internal, sponsor and FDA) at
the conclusion of their audits to review findings.
4
GA-102, Responsibilities of Research Team
Date of version: 12/29/2010
Replaces previous version: 07/01/2009


Clinical Research
Coordinator
Data / Finance Analyst
Develop organizational aids and checklists to
facilitate patient recruitment and enrollment as well
as the collection of complete and accurate study
data.
Design appropriate recruitment strategies and track
study enrollment.
Enroll subjects in studies and manage their
participation according to ethical, regulatory, and
protocol-specific requirements.
Maintain the regulatory and study files for each
research project.
Participate in quality assurance activities (monitoring
visits, internal audits, sponsor audits, FDA audits).
Communicate with the IRB as appropriate.

Research team
Fulfill those job responsibilities specific to that job
title according to federal regulations and guidelines
as well as the appropriate SOPs (Attachments E, F,
G and H for job descriptions and qualifications).
5
Attachment A
FORM FDA 1572
To retrieve (PDF) format of the above form go to website:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf
This form may be completed electronically.
Attachment B
Financial Disclosure Form for
Research Studies
(Applies to all studies greater than minimal risk)
Full Study Title:
Principal
Investigator:
Sponsor Name:
“Investigator” means any listed or identified investigator or sub-investigator who is directly involved in the
treatment or evaluation of research subjects. The term also includes the spouse and each dependent child
of the investigator.
Indicate, by answering the following questions, any financial interests or
arrangements with the sponsor of the study you are seeking approval for.
Yes
No
Will there be or has there been compensation made to the investigator of which the value
could potentially influence and/or affect the study outcome? If yes, please explain:
Does the investigator have a proprietary interest in the tested product, including but not
limited to, a patent, trademark, copyright or licensing agreement? If yes, please explain:
Does the investigator have an equity interest in the study sponsor (i.e. any ownership
interest, stock options or other financial interest whose value cannot be readily
determined through reference to public prices? If yes, please explain:
Does the investigator have an equity interest in the sponsor, or any of its affiliates, of a
publicly held company that exceeds $50,000 in value? The requirement applies to
interests held during the time the clinical investigator is carrying out the study and for one
(1) year following completion of the study. If yes, please explain:
Has the investigator or the investigator’s institution received significant payments from
the sponsor, with a cumulative monetary value of $25,000 or more? This includes
compensation in the form of equipment or retainers for ongoing consultation or
honorariums. This excludes the costs of conducting the clinical study or other clinical
studies. This requirement applies during the study and for one (1) year following
completion of the study. If yes, please describe (i.e. speaking engagements, consulting,
Board work, product development, etc.):
I certify that the information provided above is accurate. I acknowledge I must promptly update this
statement and notify Saint Mary’s Health Care Research & Innovation Department at 616-685-5213 if any
relevant changes occur in the course of this investigation. I agree to update this form annually until
study closure.
_________________________
Printed Name of Investigator
____________________________
Signature
______________________
Date
Attachment C
Form FDA 3455
To retrieve (PDF) format of the above form go to website:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048310.pdf
This form may be completed electronically.
Attachment D
DELEGATION of RESPONSIBILITY FORM (SAMPLE)
I, _
MD, located at
am Principal Investigator for Protocol #
____
____
____
____
entitled
I have ensured that the individuals listed below are properly qualified and have received appropriate training. Based
upon this, I have delegated the following responsibilities to the individuals named below, and assert that these
duties will be performed under my direct supervision:
RESPONSIBILITY
Administration
PERSONNEL
DATE
Contract negotiations
Fiscal management
Strategic planning
Patient database
Performance tracking
Quality assurance
Project Management
IRB submissions & communications
Patient recruitment activities
Sponsor, CRO contact
Regulatory files creation and maintenance
Data management/CRF completion
Adverse event reports
Organizational tools
Office staff training
Storing, dispensing, accounting for study drug
Overall study drug accountability
Storing study documents
Subject Management
Screening subjects for eligibility
Obtaining informed consent
Subject education
Monitoring patient compliance
Subject enrollment and follow-up
Clinical assessments
Adverse event determination
Source documentation
Appointment scheduling
___
Signature
/
_/__
Date
Attachment E
PRINCIPAL INVESTIGATOR ROLES & RESPONSIBILITIES
(Sample)
PURPOSE:
PROMOTES GOOD CLINICAL PRACTICES IN THE CONDUCT OF
CLINICAL INVESTIGATIONS
by
assuring adherence to protocol requirements, protecting the rights and
welfare of subjects, assuring the integrity of data generated at the site and
directing the conduct of the clinical investigation according to federal and
state regulations and guidance documents.
ESSENTIAL JOB RESULT:
1. PROVIDES INVESTIGATOR QUALIFICATIONS AND AGREEMENTS
by
 maintaining a current, up-to-date curriculum vitae
 maintaining current licensure to practice
 providing the sponsor and IRB with documentation of credentials as
requested
 demonstrating the proper education, training and experience to conduct the
clinical investigation
 assuming responsibility for the conduct of the clinical investigation
 signing the Form FDA 1572 as appropriate
 signing the protocol as required
 signing sponsor contract(s) as appropriate
 documenting the financial aspects of the trial
 disclosing conflicts of interest as described in the regulations
2. ASSURES PROTOCOL COMPLIANCE
by
 possessing a thorough understanding of the requirements of each protocol
 determining that inclusion/exclusion criteria are applicable to the study
population
 assuring recruitment goals are reasonable and attainable
 assessing overall protocol feasibility
 following the trial’s randomization procedures
 not implementing any protocol deviation or changes without agreement by
the sponsor and prior review and approval by the IRB (except to eliminate
immediate hazards to the subject)
 reviewing the inclusion/exclusion criteria, schedule of visits, end point criteria
and investigational article use with the research team
PRINCIPAL INVESTIGATOR ROLES & RESPONSIBILITIES
(SAMPLE)
ESSENTIAL JOB RESULTS:
3. ASSURES INITIAL AND ONGOING REVIEW BY A DULY CONSTITUTED IRB
by
 providing the IRB with adequate information to initially review the study (i.e.,
protocol, investigator’s brochure, informed consent form, recruitment
advertisements and any written information to be given to subject(s)
 providing the IRB with documents for ongoing review (i.e., amendments to
the protocol, adverse events, deviations or new information)
 securing written IRB approval prior to initiating the study or instituting any
changes to the protocol as approved
 providing written summaries of the trial status to the IRB annually, or as
requested
 providing written information of premature termination or suspension of a trial
 providing the IRB with all documents subject to their review
4. DETERMINES ADEQUATE RESOURCES ARE AVAILABLE TO CONDUCT
THE STUDY
by
 having adequate number of qualified staff to conduct the study
 having adequate facilities to conduct the study
 assuring he/she has adequate time to conduct and supervise the study
5. MANAGES THE MEDICAL CARE OF SUBJECTS
by
 assuring that a qualified physician (PI or sub-investigator) is responsible for
all trial-related medical decisions
 assessing subject compliance with the test article and follow-up visits
 assessing subject’s response to therapy
 evaluating for adverse experiences
 ensuring that medical care is provided to a subject for any adverse event(s)
 informing a subject when medical care is needed to treat an intercurrent
illness(es)
 informing the subject’s primary physician about their participation in the trial
6. PROTECTS THE RIGHTS AND WELFARE OF SUBJECTS
by
 reporting all serious adverse events immediately to the sponsor and IRB
assuring that the informed consent form contains all the elements required
by CFR 56 and 45
 obtaining a signed and dated informed consent from the subject or subject’s
legal representative prior to initiating any study-related procedures
 informing the subject or legal representative about all aspects of the clinical
trial
 providing new information about the study or test article(s)
PRINCIPAL INVESTIGATOR ROLES & RESPONSIBILITIES
(SAMPLE)
ESSENTIAL JOB RESULTS:







ensuring subject confidentiality
providing the subject or subject’s legal representative with a copy of the
signed and dated informed consent form
assuring that the informed consent form is in language that is understandable
to the subject
securing a witness to the informed consent process when the subject or legal
representative is unable to read
allowing ample time and opportunity for the consent process and answering
questions about the trial to the satisfaction of the subject or legal
representative
securing consent/assent from minors and mentally impaired subjects as
appropriate
following emergency use guidelines for waiver of consent in emergency
situations as directed by the federal regulations and IRB policy and
procedures
7. ASSURES VALIDITY OF THE DATA REPORTED TO THE SPONSOR
by
 ensuring the accuracy, completeness, legibility and timeliness of case report
forms
 ensuring that case report forms accurately reflect source documents
 explaining any discrepancies between source documents and case report
forms
 endorsing changes or corrections to a case report form
8. ASSURES DOCUMENTATION OF STUDY-RELATED PROCEDURES,
PROCESSES AND EVENTS
by
 documenting deviations from the approved protocol
 documenting and explaining premature unblinding of the investigational
product(s)
 documenting that informed consent has been obtained from the subject or
legal representative
 ascertaining the reason for a patient’s premature study withdrawal
 documenting adverse experiences
 complying with written procedures to document changes to data and/or case
report forms
 maintaining trial documents as required by the regulations and sponsor for
the appropriate timeframe and under secure conditions
 providing study reports as requested by the sponsor, IRB and regulatory
authority(ies)
PRINCIPAL INVESTIGATOR ROLES & RESPONSIBILITIES
(SAMPLE)
ESSENTIAL JOB RESULTS:
9. ASSURES THE PROPER USE AND STORAGE OF INVESTIGATIONAL
AGENTS
by
 being thoroughly familiar with the use of the investigational product(s)
 reading the current investigator’s brochure, product insert, or other source
information
 assuming responsibility for the investigational product at the trial site
 ensuring the proper use and storage of the investigational product(s) at the
trial site
 reviewing the proper use of the study article(s) by the subject(s)
10. DIRECTS SITE OPERATIONS
by
 communicating effectively with subjects, research team, IRB and sponsor
 meeting regularly with the research team to discuss subject participation and
protocol progress
 assuring that all research staff are informed about the protocol and
investigational agents
 being knowledgeable about regulatory requirements and GCP standards
 preparing for and attending investigator and start-up meetings
 participating in monitoring visits and audits as appropriate
 permitting monitoring and auditing by the sponsor and appropriate regulatory
authorities
 making available to monitors, auditors, IRB and regulatory authority(ies) all
requested trial-related records
 delegating authority at the site appropriately
 assuring that all research staff are informed about their trial-related duties
and functions
 maintaining a list of qualified persons and their corresponding trial-related
delegated duties
11. MAINTAINS PROFESSIONAL AND TECHNICAL KNOWLEDGE
by
 attending educational workshops
 reviewing professional publications
 participating in professional societies
Attachment F
JOB DESCRIPTION
CLINICAL RESEARCH COORDINATOR
Job Code:
608
FLSA:
Exempt
Revision Date:
July 2007
SUMMARY
Department: Research & Innovation
Reports to: Director, Research & Innovation
Approved by:
VP, Patient Care Services
Coordinates and participates in clinical research studies conducted by principal investigator(s) at Saint Mary’s
Health Care, including a variety of complex activities involved in the collection, compilation and analysis of
clinical research data, and oversees the screening for recruitment of research participants. Maintains 24-hour
responsibility for the implementation and maintenance of clinical research studies including communication
regarding protocol changes, completion of records, and IRB applications.
QUALIFICATIONS
Education
Minimum:
Preferred:
Graduation from an accredited degree program in a clinical field such as Registered
Nurse (RN) BSN program plus two years of clinical trial research experience
Master’s degree in Nursing
Credentials/Licensure
Minimum:
Current valid Michigan licensure or certification in specialty field (Registered Nurse) as
applicable. CPR certification or acquisition within 90 days of employment.
Preferred:
Clinical research certification
Related Experience
Minimum:
Successful completion of department based research orientation program upon hire.
Two (2) years prior clinical trial experience. Prior experience in clinical monitoring or as
a study coordinator required.
Other Knowledge, Skills and Abilities
Minimum:
Ability to read and interpret documents, operating and maintenance instructions, and
procedure manuals. Ability to write research reports and correspondence. Excellent
written and verbal communication, interpersonal, and presentation skills. Time
management and organizational skills. Self-directed. Ability to make quality,
independent decisions. Analytical and strong problem solving skills. Ability to work
effectively and efficiently under tight deadlines, high volumes and multiple interruptions.
Computer Competency
Ability to use word processing and patient record keeping software. Shows how to use
(through a competency assessment) a standard desktop and windows based computer
system, including a basic understanding of email, e-learning, intranet and computer
navigation. Ability to use other software as required to perform the essential functions
of the job.
Physical/Mental
Minimum:
Independently mobile (constantly); computer work / keyboarding (frequently); able to lift
charts/files/equipment weighing up to 40 pounds (occasionally), ability to handle multiple
conflicting demands, ability to work long hours. Valid Michigan Driver’s License. While
performing the duties of this job, the employee is regularly required to sit and talk or
hear.
WORKING CONDITIONS
Exposed to a variety of attitudes, personalities and reactions from employees and other members of the health
care team, medical staff, patients and family members, etc. Possible exposure to a variety of contagious
diseases and/or radioactive or other hazardous materials found in a health care environment. Flexible hours
based on patient/study need. The noise level is usually moderate. Current unrestricted Michigan driver’s
license, automobile insurance, and available automobile (based on SMHC entity). Must have transportation
available to meet with patients, transport documents, and other items to specified locations outside the hospital
AGES OF PATIENTS SERVED
 Newborns
 Pediatrics
 Adolescents
Adults
 Geriatrics
 NA
ORGANIZATIONAL EXPECTATIONS




Flexibility – Demonstrates exceptional ability and willingness to take on new and additional
responsibilities. Embraces new ideas and cultural differences while managing competing priorities.
Accountability – Willingly accepts personal responsibility for decisions, actions, attitudes and behaviors,
which contribute to the overall effectiveness of the organization. Communicates effectively, follows through
on assignments, uses resources efficiently, participates in learning opportunities and treats others with
respect and dignity.
Excellence – Serves as a role model and performs job responsibilities to the highest standards in every
situation. Delivers “Something More” that ensures a more complete and personally satisfying experience
for every customer.
Focus – Understands and demonstrates behaviors consistent with the mission and values of the
organization while contributing to the overall success of the strategic plan. All actions are rooted in
providing excellent customer service.
ESSENTIAL FUNCTIONS









Coordinates and participates in clinical research studies conducted by principal investigators at Saint
Mary’s Health Care, including study start up, participating in a variety of complex activities involved in the
collection, compilation, documentation and analysis of clinical research data. Assists in the determination of
guidelines for the collection of clinical data and/or administration of clinical studies.
Ensures compliance with study protocols, regulatory agency guidelines, and identification of
inconsistencies and monitoring of patient progress including completion of documentation and reporting of
adverse events. Prepares IRB applications, amendments to protocols, annual reports and serves as point
person to IRB in absence of PI.
Coordinates and implements procedures to support the collection of data from processes and procedures
to collect data from source documents including (but not limited to) patient records, interviews,
questionnaires and surveys, tests and other sources. Skilled in document coding, evaluation and
interpretation of data. Preparation of study related regulatory documents as well as acquisition and
preparation of study samples, cultures, tissues and other lab specimens for transport to study sponsors.
Evaluates and interprets clinical data and preparation of presentations, papers, reports and analyses in
conjunction with principal investigator(s). Collaborates on preparation of manuscripts for publication and
opportunities for the development of investigator-initiated studies.
Develops forms, questionnaires, assists in writing procedure manuals for data collection and coding.
Keeps abreast of industry standards through the review of journals, abstracts, and scientific literature.
Guides interdepartmental coordination for study protocol; integration of supportive staff in research roles
including orientation of new staff.
Responsible for research participant education related to research protocols and critical decision making
associated with study participation including interpretation of clinical indicators and communication with PI
and appropriate physicians.
Performs other duties as assigned.
SYSTEMS AND INFORMATION
To ensure appropriate utilization of Protected Health Information (PHI) associated with the Health Insurance
Portability and Accountability Act (HIPAA) and Saint Mary’s Confidentiality of Information Standards, as well as
other regulatory entities, individuals employed in this position will be granted systems and information access
as appropriate for this position.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by the
people assigned to this classification. They are not intended to be construed as an exhaustive list of all
responsibilities, duties and skills required of personnel so classified. The listed duties may be changed at the
discretion of the incumbent’s supervisor.
Attachment G
JOB DESCRIPTION
CLINICAL RESEARCH DATA ANALYST
Job Code:
609
FLSA:
Exempt
Revision Date: July 2007
SUMMARY
Department: Research & Innovation
Reports to: Director, Research & Innovation
Approved by: Director, Research & Innovation
Under supervision of the Director and according to established policies and processes serves as internal consultant and
expert related to operational and clinical research initiatives, explores and recommends measurement strategies, and
integrates data from multiple sources. Provides education and training to providers and other health care staff related to
use of data and statistics for data based decision-making.
QUALIFICATIONS
Education
Minimum:
Bachelor’s degree in Nursing, Information Systems, Business Administration or related field that
utilizes strong technical computer/math knowledge and statistical analysis.
Preferred: Master’s degree in relevant field.
Credentials/Licensure
Minimum: Valid Michigan driver’s license.
Preferred: Valid Registered Nurse license in the state of Michigan
Related Experience
Minimum: Three (3) or more years of clinical experience in clinical trials and/or clinical trial analysis involving
experience with clinical protocols, clinical data analysis, database querying tools and knowledge of
relational database structures and methodologies. Familiarity with requirements of Good Clinical
Practice and coding dictionaries. Knowledge of ICD 9 coding structure and medication
classifications. Knowledge of medical/clinical terminology. 1 year previous project management
experience.
Preferred: Five years clinical trial experience. Experience with SAS, SPSS, ACCESS database systems. A
strong theoretical and practical background in epidemiology and computer base design for
research. Skill in data analysis techniques.
Other Knowledge, Skills and Abilities
Minimum:
 Analytical ability in order to participate in the strategic planning of the data resources: collect, analyze and
report data; analyze and interpret discrepancies, issues or problems to ensure data accuracy and integrity; to
identify appropriate sampling techniques; obtain advice when precedents are unclear or unavailable and to
determine methods for ensuring compliance with functional/organizational/service line policies and procedures.
 Demonstrated communication and/or interpersonal skills to communicate with internal and external
customer/stakeholders related to data abstraction, manipulation, and analysis, and to effectively inform, instruct
and facilitate the understanding and use of generated data.
 Technical knowledge of and ability to understand and ability to utilize spreadsheets, databases, and statistical
analysis software programs.
 Familiarity with the extraction and manipulation of data from disparate sources to support the study of clinical,
functional, service and cost outcomes.
 Technical knowledge of health-related data involved in clinical improvement, including medical record,
administrative and financial data. Working knowledge of public health and other external data sources.
 Ability to work with a team in identifying sources of data and methodology for collection.


Demonstrated familiarity with the application of computers in data analysis, use of data based decision-making
methodologies. Proven ability to build positive relationships with key stakeholders.
Demonstrated ability to present unfamiliar detailed information to others in a readily comprehensible way.
Demonstrated ability to work with little direction while being sensitive to issues requiring physician and/or
committee involvement, read, analyze, and interpret professional journals, technical procedures, or
governmental regulations, and write reports, business correspondence, procedures and policies
Computer Competency
Shows how to use (through a competency assessment) a standard desktop and windows based computer
system, including a basic understanding of email, e-learning, intranet and computer navigation. Ability to use
other software as required to perform the essential functions of the job.
Physical/Mental
Minimum: Independently mobile (constantly); computer work / keyboarding (frequently); able to lift
charts/files/equipment weighing up to 20 pounds (occasionally), ability to handle multiple conflicting demands,
ability to work long hours.
WORKING CONDITIONS
Exposed to a variety of attitudes, personalities and reactions from employees and other members of the health care
team, medical staff, patients and family members, etc. Possible exposure to a variety of contagious diseases and/or
radioactive or other hazardous materials found in a health care environment.
AGES OF PATIENTS SERVED
 Newborns
 NA
 Pediatrics
 Adolescents
 Adults
 Geriatrics
ORGANIZATIONAL EXPECTATIONS




Flexibility – Demonstrates exceptional ability and willingness to take on new and additional responsibilities.
Embraces new ideas and cultural differences while managing competing priorities.
Accountability – Willingly accepts personal responsibility for decisions, actions, attitudes and behaviors, which
contribute to the overall effectiveness of the organization. Communicates effectively, follows through on
assignments, uses resources efficiently, participates in learning opportunities and treats others with respect and
dignity.
Excellence – Serves as a role model and performs job responsibilities to the highest standards in every situation.
Delivers “Something More” that ensures a more complete and personally satisfying experience for every customer.
Focus – Understands and demonstrates behaviors consistent with the mission and values of the organization while
contributing to the overall success of the strategic plan. All actions are rooted in providing excellent customer
service.
ESSENTIAL FUNCTIONS
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Maintains, updates and improves the quality of research data information systems.
Participates in the design of research protocols and feasibility assessments of study protocols.
Designs and constructs database programs for retrieval, storage and analysis of research data sets.
Acts as liaison between the Department of Research & Innovation and health care providers or researchers with
data extraction and analysis needs.
Uses medical knowledge to access accuracy and quality of data imported into electronic medical records from
multiple data systems.
Develops and documents data quality assurance procedures to access sources of data inaccuracies.
Provides statistical, methodological and research support to the Director.
Serves as source of expertise and internal consultant on measurement techniques, including statistical process and
improvement statistics
Links data from disparate sources into data sets and designs, develops and maintains independent databases
Functions as an expert with regard to internal/external data sources. Seeks out and identifies new sources of data
as needed to support research activities. Develops methods of securing data from identified sources. Identifies
issues and problems or concerns related to data collection and reporting and assists in the standardization of data
collection and reporting processes and procedures, and implementation and evaluation of new policies and
procedures as appropriate.
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Serves as a liaison between assigned clinical and operational services and departments and other internal and
external customers/stakeholders with regard to gathering and providing data, resolving data
collection/analysis/measurement issues, analyzing data and identifying trends, recommending improvements,
explaining policies and procedures and assisting clinicians in understanding the use of data for the improvement of
practice
Remains current regarding latest developments/trends in data management, statistical analysis and measurement,
methodology/technology by attending and participating in related seminars, in-services, and meetings; maintaining
professional affiliations in related organizations and reading current literature and journals related to field of work
Participates in special projects and development of analyses as directed
Performs other duties as assigned
SYSTEMS AND INFORMATION
To ensure appropriate utilization of Protected Health Information (PHI) associated with the Health Insurance Portability
and Accountability Act (HIPAA) and Saint Mary’s Confidentiality of Information Standards, as well as other regulatory
entities, individuals employed in this position will be granted systems and information access as appropriate for this
position.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by the people
assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties
and skills required of personnel so classified. The listed duties may be changed at the discretion of the incumbent’s
supervisor.
JOB DESCRIPTION
SR FINANCIAL ANALYST CLINICAL RESEARCH
Job Code:
606
FLSA:
Exempt
Revision Date: June 2007
Department: Research & Innovation
Reports to: Director, Research & Innovation
Approved by: Director, Research & Innovation
SUMMARY
Part of the Research & Innovation team at Saint Mary’s Health Care interfacing with the Director of Research &
Innovation, internal and external customers. Serves as a business consultant/financial advisor to the department
regarding financial and business decisions related to the operations of the department. Responsible for the
development, implementation, management and overall coordination of systems and information for the support of
financial and operational performance and CQI within the department. Serves as a consultant/systems analyst to
address information management improvements and recommends more integrated approaches to collecting,
reporting and using financial and operational performance data to support the goals of the Department of Research
& Innovation. Takes initiative and continually strives to improve processes.
QUALIFICATIONS
Education
Minimum:
Preferred:
Bachelor degree in Accounting, Finance, or Engineering
Master degree in Business (MBA), Master of Healthcare Administration (MHA), Accounting
(MSA), Engineering or Certified Public Accounting (CPA)
Credentials/Licensure
Minimum:
Preferred:
Related Experience
Minimum:
Preferred:
Three to five years of healthcare experience in financial modeling (NPV & IRR), business
pro formas, operating and capital budgeting, cost accounting / product line analysis,
benchmarking, productivity and strategic financial modeling. Demonstrated experience in
conducting training / educational sessions for management.
Previous clinical research experience. Understanding of hospital / clinic operations, project
management skills, and process improvement techniques. Knowledge of healthcare
industry, reimbursement, payors, DRG / APC, diagnosis codes, and charge master.
Other Knowledge, Skills and Abilities
Minimum:
Interpersonal skills necessary in order to facilitate meetings, communicate with various
constituencies and demonstrate success in fostering relationships with management, staff
and external customers / groups. Excellent customer service skills in providing services to
management and external customers.
Preferred:
Leadership skills to motivate and influence others to achieve results without direct line
authority. Strong creativity and problem solving skills.
Computer Competency
Minimum:
Advance computer knowledge and skills related to database structures, query languages,
software interfaces and software modeling skills to support organizational financial and
decision support requirements. Ability to communicate and coordinate software / server
upgrades in partnership with Trinity Information Services.
Shows how to use (through a competency assessment) a standard desktop and windows
based computer system, including a basic understanding of email, e-learning, intranet and
computer navigation. Ability to use other software as required performing the essential
functions of the job. Microsoft Office (Excel, Access, PowerPoint and Word).
Preferred:
Business Objects (RSW and Plan) Activity Based Costing, Strata Cast, Solucient Action
IO, SQL, Visual Basic, Cognos, and PeopleSoft General Ledger experience.
Physical/Mental
Minimum:
Must posses the ability to: hear, speak, and read (constantly); develop constructive
alternatives and analyze situations and information (frequently); organize and present
information, projects, and programs while demonstrating attention to details (frequently);
operate computers, CRT, and keyboard; bend, stoop, lift (10-20 pounds), twist, turn, and
reach to operate computer, audio-visual equipment (frequently).
WORKING CONDITIONS
Must work well in an environment that warrants varied and/or extended hours with changes in workload and
priorities to keep pace with the industry and organizational priorities; thrive in a fast-paced, multi-customer
environment, with conflicting needs which some may find stressful.
AGES OF PATIENTS SERVED
 Newborns
 Pediatrics
See department specific checklist.
 Adolescents
 Adults
 Geriatrics
 NA
ORGANIZATIONAL EXPECTATIONS
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Flexibility – Demonstrates exceptional ability and willingness to take on new and additional responsibilities.
Embraces new ideas and cultural differences while managing competing priorities.
Accountability – Willingly accepts personal responsibility for decisions, actions, attitudes and behaviors, which
contribute to the overall effectiveness of the organization. Communicates effectively, follows through on
assignments, uses resources efficiently, participates in learning opportunities and treats others with respect and
dignity.
Excellence – Serves as a role model and performs job responsibilities to the highest standards in every
situation. Delivers “Something More” that ensures a more complete and personally satisfying experience for
every customer.
Focus – Understands and demonstrates behaviors consistent with the mission and values of the organization
while contributing to the overall success of the strategic plan. All actions are rooted in providing excellent
customer service.
ESSENTIAL FUNCTIONS
The Clinical Research Financial Analyst will assist with all matters of the financial management of the Department
of Research & Innovation
1) Coordinates the development of clinical trial budgets and participates in the negotiation of clinical trial
budgets with sponsors.
2) Interfaces with clinical service lines to assess the patient care costs, overhead, staff and other indirect and
direct costs associated with sponsored clinical trials and investigator initiated studies.
3) Establishes payment, tracking and invoicing systems for all research studies.
4) Works with the Clinical Research staff to identify patients enrolled in studies to ensure compliance and
proper billing. Coordinates the real-time tracking of patient progress on studies, patient care costs to be
charged to studies, cross department reimbursement for study related tests and activities, and coordination
of study billing, compliance and interface with all departments involved in research.
5) Responsible for financial tracking and accountability to include interpretation of budget variances,
productivity benchmarks and cost accounting standards, input into operational and capital budgets,
reimbursement and expenditures, financial reports and budget projections.
6) Reviews and participates in the development of research study contracts.
7) Ability to utilize and understand software query tools to gather, analyze and interpret information when
advising/consulting management on financial and business decisions associated with research.
8) Assist management in compliance with all applicable laws, rules and regulations.
9) Other duties as assigned.
SYSTEMS AND INFORMATION
To ensure appropriate utilization of Protected Health Information (PHI) associated with the Health Insurance
Portability and Accountability Act (HIPAA) and Saint Mary’s Confidentiality of Information Standards, as well as
other regulatory entities, individuals employed in this position will be granted systems and information access as
appropriate for this position.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by the people
assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities,
duties and skills required of personnel so classified. The listed duties may be changed at the discretion of the
incumbent’s supervisor.
B
S
Attachment H
JOB DESCRIPTION
CLINICAL RESEARCH ASSISTANT
Job Code:
603
FLSA:
Non-Exempt
Revision Date:
September 2007
Department: Research & Innovation
Reports to: Director, Research and Innovation
Approved by: VP Patient Care Services
SUMMARY
Provides support to the Director, the Department of Research & Innovation, and the Institutional Review Board (IRB)
within Saint Mary’s. Responsible for the preparation of regulatory submission packages and essential documents for
Institutional Review Board (IRB) for study. Communicates/collaborates with Principal Investigators, research staff and
a variety of people at various levels within and outside the organization (i.e. directors, sponsors, state and accrediting
agencies). Initiates/develops/ composes written communication; gathers/enters and prepares data. Decision making
authority extends beyond prioritizing of own work to independent problem solving and managing of
schedules/priorities for the organizational processes supporting clinical research. Because of the nature of this highly
visible position, a high level of administrative skills, professionalism and tact is expected of individuals in the role.
QUALIFICATIONS
Education
Minimum:
Preferred:
Associates degree in business or related field or equivalent level of
education/experience (high school diploma and two to three years of clinical research
assistant/administrative or similar experience).
Bachelors degree in business or related field or equivalent education and experience
(associate degree and three to five years experience).
Credentials/Licensure
Minimum:
Preferred:
Human Subjects Protection certificate. CPS - Certified Professional Secretary from
the IAAP -International Association of Administrative Professionals
Related Experience
Minimum:
Preferred:
Four years administrative/executive experience. One to two years’ research/IRB experience.
Three to five years’ research/IRB experience.
Other Knowledge, Skills and Abilities
Minimum:
Preferred:
Time management, prioritization and organizational skills including demonstration of
an ability and willingness to plan, organize and accomplish tasks accurately and in a
timely manner, to exercise sound judgment under pressure and to manage multiple
and competing activities simultaneously. Excellent communication skills including the
ability to demonstrate diplomacy and tact, compose, spell, edit/proof, utilize
appropriate grammar, and to relate in an appropriate interpersonal manner to all levels
and types of individuals in a fashion that will earn credibility, respect, confidence and
will generate mutual support. An understanding of organizational dynamics and
administrative procedures and protocols. Accurate typing skills of 60-65 words per
minute. Experience with and knowledge of general office equipment such as copier,
printers, and fax machines in order to operate and maintain equipment and to
troubleshoot minor problems. High degree of trust and demonstration of the ability to
respect and appropriately handle confidential and sensitive information.
Project Management skills
Computer Competency
Shows how to use (through a competency assessment) a standard desktop and windows
based computer system, including a basic understanding of email, e-learning, intranet and
computer navigation. Ability to use other software as required to perform the essential
functions of the job. High proficiency with Office products, spreadsheets, graphics, database
applications also required.
Physical/Mental
Preferred:
Sitting for long periods of time (frequently); mobile; bending, stooping and reaching above
head and lifting and lifting and carrying as part of daily responsibilities (occasionally).
Keyboard, repetitive tasks of typing and phone use (frequently). Ability to speak is required.
Visual acuity, including near and far vision, depth perception and color distinction is required.
Manual dexterity is necessary in order to operate a keyboard. Hearing is required for
extensive telephone and in person communications.
WORKING CONDITIONS
General office conditions. Ability to function in a dynamic, fast-paced team environment and to cope with ambiguity,
time constraints, and other daily stressors in an effective and appropriate manner.
AGES OF PATIENTS SERVED
 Newborns
 Pediatrics
See department specific checklist.
 Adolescents
 Adults
 Geriatrics
 NA
ORGANIZATIONAL EXPECTATIONS




Flexibility – Demonstrates exceptional ability and willingness to take on new and additional responsibilities.
Embraces new ideas and cultural differences while managing competing priorities.
Accountability – Willingly accepts personal responsibility for decisions, actions, attitudes and behaviors which
contribute to the overall effectiveness of the organization. Communicates effectively, follows through on
assignments, uses resources efficiently, participates in learning opportunities and treats others with respect and
dignity.
Excellence – Serves as a role model and performs job responsibilities to the highest standards in every situation.
Delivers “Something More” that ensures a more complete and personally satisfying experience for every
customer.
Focus – Understands and demonstrates behaviors consistent with the mission and values of the organization
while contributing to the overall success of the strategic plan. All actions are rooted in providing excellent
customer service.
ESSENTIAL FUNCTIONS

Ensures that submitted research is reviewed efficiently and consistent with regulations by having a thorough
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knowledge of and ability to apply HHS/FDA federal regulations, clear understanding and adherence to human
subjects protection and HIPAA
Maintains accurate records of IRB actions and oversees the accurate and timely processing, tracking, and filing
of submissions to and actions by the IRB.
Ensures that Investigators and Sponsors are informed of the actions and findings of the IRB
Accountable for adhering to Standard Operating Procedures (SOPs), regulatory guidelines, assisting with study
start up, tracking timeliness, reports and procedures.
Ensures that continuing review of research is conducted appropriately and in a timely manner
Serves as IRB interface for subjects, Investigators, Sponsors and regulatory agencies
Responsible for preparation and maintenance of study files and initiates/develops/composes written and standard
correspondence. Takes, transcribes and distributes minutes. Prepares PowerPoint presentations.
Communicates and collaborates with research staff, sponsors, principal investigators, state and accrediting
agencies, etc. regarding various subject matters. Gathers, enters and prepares data for analysis and generates
reports based on established processes. Tracks payroll/budget/expenses. Researches problems and able to
see big picture.
Manages the schedule and calendar of appointments and meetings for director. Coordinates travel/conference
arrangements and itineraries and performs general office duties as assigned to ensure effective running of the
area.
Coordinates and manages projects. Directs and maintains accountability for complex, multi-faceted programs
with minimal direction from supervisor.
Performs other duties as assigned.
SYSTEMS AND INFORMATION
To ensure appropriate utilization of Protected Health Information (PHI) associated with the Health Insurance
Portability and Accountability Act (HIPAA) and Saint Mary’s Confidentiality of Information Standards, as well as other
regulatory entities, individuals employed in this position will be granted systems and information access as
appropriate for this position.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by the people
assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities,
duties and skills required of personnel so classified. The listed duties may be changed at the discretion of the
incumbent’s supervisor.