University of Pennsylvania
NOTE: This job description is provided as a sample. Be sure to review each item below and
ensure it is appropriate for the specific job you are posting. You may also add items not
included on this list that are specific to the job you are developing.
TITLE/GRADE: Clinical Research Coordinator C/27 (exempt)
SOURCE OF SUPERVISION:
Supervisor, Clinical Research Coordinators
DUTIES:
This individual will work independently with minimal supervision. May act in a lead capacity or as back-up
to supervisor.
Clinical Research Responsibilities:














Coordinate the conduct of Phase I – IV clinical trials.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as
required.
Activate participation in the development of investigator initiated protocol case report forms and
progress notes
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Organize and maintain all documentation required by sponsor or CRO (source documentation,
case report forms, study and regulatory binders, and patient binders).
Resolve data queries with sponsor and CROs
Recruit, screen and enroll potential study patients as specified per protocol.
Process and ship blood, urine and serum specimens for each trial
Schedule patient visits and any necessary testing
Attend Investigator Initiation meetings
Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines.
Obtain records required to complete case report forms.
Show vigilance in patient safety, protocol compliance, and data quality.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Regulatory Responsibilities:




Prepare and process all Institutional Review Board (IRB) documentation through the IRB,
including submissions, continuing reviews, amendments and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and clinical
research organizations (CROs).
Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA
Form 1572, deviation and exception memos, physicians and coordinators’ CVs and medical
licenses, record of IRB certification and compliance).
Resolve regulatory related queries with IRB, study sponsors and CROs.
BACKGROUND CREDENTIALS:
A BA/BS and 4- 6 years clinical trial/clinical research experience; or equivalent. Effective problem solving
abilities. Effective communication and writing skills. Ability to multi-task. Demonstrated ability to work as
part of a team as well as independently. Knowledge of IRB and human research protection regulations.
COMPETENCIES:
Action Oriented; Boss Relationships; Integrity and Trust; Interpersonal Savvy; Learning on the Fly;
Listening; Organizing; Planning; Priority Setting; Problem Solving; Self-Knowledge; Standing Alone;
Technical Learning; Time Management