Clinical Research Coordinator C

University Overview

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The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Clinical Research Coordinator C

Clinical Research Coordinator C

• Coordinate the conduct of Phase I – IV clinical trials.
• Participate in the conduct of audits by study sponsors, Clinical Research Organizations (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.
• Utilization of the EMR to research tracking and optimization.
• Ability to start up and support multi stie trials
• Ability to operationalize a clinical research protocol and build synergistic partnerships to execute
• Participate in CRF testing and possibly design.

• 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 CROs.
• Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators’ CVs and medical licenses, record of IRB certification and compliance).
• Resolve regulatory related queries with IRB, study sponsors and CROs.

• Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; (2) effective verbal and written…