CLINICAL RESEARCH COORDINATOR

The CRC will work at the Foot & Ankle Center in Bryn Mawr, Pennsylvania. The center is dedicated to conducting basic, clinical, and translational research on podiatric conditions and diseases to advance foot and ankle health and treatment options.

The CRC will focus on research initiatives related to podiatric conditions, treatments, and interventions. This includes research in foot and ankle health, diabetic foot care, sports injuries, and congenital podiatric abnormalities. The role will involve working with a multidisciplinary team committed to advancing podiatric care through research, education, and quality improvement initiatives.

The Clinical Research Coordinator will be a key member of the Research Team working closely with the Principal Investigator in coordinating clinical, behavioral, and community-engaged research to improve podiatric health outcomes. Under the direction of the Principal Investigator(s), Co-Investigators, and Research Manager, the Clinical Research Coordinator will perform various research duties for multiple research and quality improvement projects.

Core responsibilities:

· Support IRB submissions and regulatory filings

· Adhere to IRB-approved protocols.

· Coordinate protocol-related research procedures, study visits, and follow-up care.

· Participate in the informed consent process of study subjects.

· Screen, recruit, and enroll patients/research participants.

· Support the safety of clinical research patients/research participants.

· Maintain study source documents.

· Under the supervision of PI, report adverse events.

· Understand Good Clinical Practice (GCP) and regulatory compliance.

· Educate subjects and families on protocol, study interventions, etc.

· Comply with institutional policies, standard operating procedures (SOPs), guidelines, HIPAA, and management of confidential materials.

· Comply with federal, state, and sponsor policies.

Related responsibilities:

· Complete case report forms (paper & electronic data capture) and address queries.

· Submit documents to regulatory authorities (e.g., IRB, FDA) and/or review/monitoring boards (e.g., DSMB, independent safety officer).

· Facilitate pre-study, site qualification, study initiation, and monitoring visits as appropriate.

· Facilitate study close-out activities as appropriate.

· Collect, process, and ship samples as applicable to the protocol.

· Schedule subject visits and procedures.

· Retain records/archive documents after study closeout.

Education Qualifications:

· Bachelor’s Degree preferred.

· Phlebotomy and/or Lab skills (MST, MSLT, etc)

Experience Qualifications:

· At least three (3) years of clinical research-related experience required.

· Prior work in a medical clinic