JOB FACT SHEET
POSITION INFORMATION
Position Number: 9627
Current Grade (if applicable): 9
Working Title: Study Coordinator
Faculty/Department: Department of Medicine, Division of Nephrology
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 Actual Hours Worked (if Part-Time): Click here to enter text.
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 If OTHER, please indicate Position Type: Click here to enter text.
Special Requirements:
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SIGNATURES: The signatures below indicate that all parties have read and discussed the content of the JFS
EFFECTIVE DATE (if different from date signed): Click here to enter a date.
FINANCIAL AUTHORIZATION:
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INCUMBENT (if applicable):
SUPERVISOR:
DEPARTMENT HEAD/TRUSTHOLDER:
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1. SIGNIFICANT CHANGES SINCE LAST REVIEW
N/A
2. POSITION SUMMARY
Working under the supervision of the Scientific Manager, the study coordinator will operate multiple
clinical research projects conducted by the Kidney Health Research Group. Activities include: conducting
study activities specific to research protocols, training and monitoring study assistants, designing data
collection forms, completing Health Canada and other regulatory applications, and coordinating
activities of external study sites as they relate to the Kidney Health Research Group.
3. RESPONSIBILITIES/ACTIVITIES: Group activities into categories and list in point form each
duty performed until the major elements of the position are represented. Review each
statement to ensure that it accurately describes what is done and briefly, how it is done.
Please indicate the percentage of time spent on each of the major activities listed
Study Coordinator activities:
Review and refine multiple research protocols conducted by the Kidney Health Research Group such as:
 Refine study procedures as required to make research protocols highly-specific and executable
(that is, logistics, resources, regulations) at internal and external study sites
 Assist the Research Administrator and Scientific Manager with study budgets
Perform study preparation and set up activities that include:
 Prepare consent forms, ethics submissions and renewals (Human Research Ethics Review
Process) and amendments
 Design and review study materials (data collections materials including data collection forms
and shadow charts)
 Complete regulatory applications to governing bodies such as Health Canada
 Develop study procedure protocols. Communicate study procedures and any changes therein to
study assistants and off-site study coordinators
Manage the conduct of the research protocols which include:
 Ensure all aspects of the study are performed within International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical
Practice and Tri-Council Policy Statement guidelines
 Train and monitor study assistant who implements the research protocols
 Coordinate and monitor ongoing participant lab (and blood) testing
 Troubleshoot for any potential quality assurance issues
 Update the Director on the progress of the study
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Internal site activities:
 Liaise with Alberta Health Services, University departments including the Research Ethic Boards
and Industry partners on issues related to study operations
 Assign tasks to study assistants; conduct their performance evaluations
External site activities:
 Gather and organize regulatory documents from all study sites (internal and external)
participating in Kidney Health Research Group studies
 Ensure external sites have adequate materials to conduct study procedures
 Ensure external sites receive necessary training to conduct study procedures; travel to study
sites to train when needed; assist in developing training modules/documents
 Monitor data collected for studies at both external sites (travel required) and local sites
 Act as primary contact and support for all external study sites; provide assistance and solutions
to external study sites as needed
Study Assistant activities:
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Identify potential participants through interactions with pertinent health care and
administrative staff, and chart reviews
Screen potential participants as per inclusion/exclusion criteria of specific protocols
Explain study protocol and procedures and obtain informed consent from participating study
subjects
Conduct study procedures of research protocols within the required timelines outlined in the
study protocol
Collect clinical and other study data through subject interview and clinical record review
(NETCARE, Nephrology Information Systems, etc.; ensure all information collected is accurate
and complete and is collected according to the methods and guidelines of each individual
research project; administer research questionnaires to study subjects using methods outlined
in the research project
Collect, process and deliver biological samples to related study laboratories; perform clinical
related study procedures such as venipuncture and bio-impedance testing if needed; documents
serious and minor adverse events for regulatory overview
Enter collected data into the appropriate electronic databases; retrieve additional data or
correct existing data; respond to database queries
Interact with any health care staff involved in the conduct of study procedures (dialysis nurses,
dialysis technicians, etc.)
Attend and participate in regularly scheduled Kidney Health Research Group staff meetings and
other meetings related to specific clinical research projects
Participate in any inside or outside study training activities
Occasional travel is required to conduct study visits at rural locations
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Data Management activities
 Assist the Database Developer and the Scientific Manager in the design of the study database
applications; create database Excel programs for small study projects
 Assist the Scientific Manager with quality assurance activities; run regularly scheduled queries of
study databases, identify gaps or errors in data and correct, revise or collect required data;
distribute quality assurance work to study assistants and research assistant
 Develop Study Assistant Manual in collaboration with the Database Developer; update and
revise manual as required
4. KNOWLEDGE: Identify the minimum formalized training/education and/or qualifications
required to prepare an individual to be functional in the position.
Post-secondary education of a Bachelor’s degree or less with up to 18 months to become functional in
the role
B.Sc in Health sciences or related field and/or professional designation in health or research field, i.e.,
Registered Nurse, CCRA/CCRP
5. INDEPENDENCE OF ACTION: Describe the initiative required, the creativity and original
thought, and also the amount of direction and control received from the supervisor or standard
practices and precedents.
A. What types of decisions are made independently?
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Submit ethic renewals and amendments
Liaise with internal and external partners
Establish timelines to complete tasks
Identify gaps in data gathering and conducts data retrieval
Develop strategies to assist external research sites with minor issues (i.e. not affecting
the overall goals and objectives of the research project
Make minor administrative revisions to study documents including the Study Assistant
Manual
Assign responsibilities to Study Assistants and Research Assistant
B. For what actions is it necessary to consult someone? Are approvals or instructions verbal or in
writing?
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Revise content of data collection tools after verbal or written consultation with the
Scientific Manager
Develop strategies for significant issues with external study sites (i.e., recruitment
issues, regulatory or GCP issues) after verbal or written consultation with the Scientific
Manager
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Assign data management tasks after verbal or written consultation with the Scientific
Manager
After written consultation from the Research Administrator and Scientific Manager, the
position will make purchases of study materials and equipment
Conduct performance evaluations on Study Assistants in written consultation with the
Scientific Manager
6. CONSEQUENCE OF ERRORS: Identify the extent of losses which result from mistakes in
judgment or poor decisions (typical instances, not rare or extreme ones), and the responsibility
for safety of others.
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Failure to monitor study data will result in incomplete or incorrect data
Failure to understand and follow study protocols can compromise the integrity of
research project
Failure to provide adequate support to external study sites can compromise the Kidney
Health Research Group relationship with collaborators or incomplete/incorrect data
collection from external study sites
7. CONTACTS: Identify the contacts and the purpose of the interaction.
A. Inside the University
Investigators, Research Ethics Boards
B. Outside the University
AHS staff, Northern Alberta Clinical Trials and Research Centre, Health Canada, Industry
Partners, and other external partners (Canadian Biosample Repository, Clinical Trials Lab
C. Information Sources
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Good Clinical Practice Guidelines
Written guidelines related to specific study procedures, i.e., study questionnaire
guidelines, dialysis unit clinical protocols, etc.
8. SUPERVISION: If this position is not required to supervise staff, please indicate “n/a”.
A. Describe all aspects of formal supervision required of this position. Please be sure to complete
Part B.
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Responsible for all aspects of supervision for 1 FTE position
Trains and monitors study assistants
Assigns work to study assistants and research assistant
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B. Please indicate how many staff members are supervised by the position.
Full-time employees: 1
Part-time employees:
Casual employees: 2
9. PHYSICAL DEMANDS: Describe the degree, frequency, severity, intensity and continuity of
physical activity and/or intense visual concentration required.
A. Activities
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Uses computers for form design, small database development, quality assurance
monitoring, data entry and for email correspondence (95%)
Travels to other study sites by care/plane to conduct study visits or train other staff (5%)
B. What types of equipment or tools are used in the job?
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Computers
Hair scissors, nail and fingernail clippers used for bio-sample collection
10. WORKING CONDITIONS: Describe the disagreeable aspects of the job environment in
relation to employee safety and comfort, and the severity and frequency of exposure to
workplace hazards.
Standard office environment
11. SIMILAR POSITIONS AT THE UNIVERSITY OF ALBERTA: Please list any position numbers,
titles, departments or incumbent names that may be considered to be similar.
12. ORGANIZATION CHART: An organization chart is mandatory for the evaluation process to
be completed. You may include this as a separate attachment or file may be pasted/
embedded below
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