Clinical Research Coordinator C

Job Description Summary

The Clinical Research Coordinator (CRC) is responsible for the execution of clinical research studies within the Department of Neurology's Stroke Division at the University of Pennsylvania.

Job Description

The candidate will carry out daily activities related industry-sponsored and federally-funded research protocols, as well as assist in the conduct of investigator-initiated research and division-specific research projects and operations.

Coordinate the conduct of Stroke division clinical trials, including but not limited to:

• Screening, recruiting and enrolling potential study patients as specified per protocol
• Data management, including data entry and query resolution
• Process and ship blood, urine, and serum specimens as specified per protocol
• Adhering to the study protocol schedule of assessments, including scheduling patient visits and conducting visits

Participate in the conduct of audits by study sponsors, Clinical Research Organizations (CROs), the FDA, and other entities as required.

Active 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).

Attend Investigator Initiation meetings

Show vigilance in patient safety, protocol compliance, and data quality.

Adhere to all University of Pennsylvania, ICF, and FDA guidelines.

Ability to start up and support multi-site trials

Ability to operationalize a clinical research protocol and build synergistic partnerships

Assist the Associate Director in keeping track of patient visits and activities for billing and invoicing

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.

Provide mentorship for more junior clinical research staff

This position is contingent upon funding.

Qualifications

• Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
• Must be detail-oriented with organizational and multi-tasking skills.
• Prior experience with IRB guidelines, policies, human subject research practices and appropriate professional skills in the execution of research protocols is preferred
• Due to varying study protocol designs and stringent project deadlines, candidates should have the ability to occasionally work outside of normal work week hours.
• Excellent interpersonal and communication skills. Must have a strong ability to communicate with clinicians, researchers, patients and families. Job may require communication with staff and patients outside of office hours.
• Ability to work with a diverse group of people
• Must be able to exercise discretion with confidential information

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $63,854.00 Annual Rate