Clinical Research Coordinator Sr.

Job Details

Responsible for the coordination and oversight of clinical research trials from start-up through close-out. Ensures that clinical trials are conducted in compliance with approved protocols, regulatory requirements and sponsor expectations.

Job Description

Study Management

• Lead daily clinical research operations and ensure activities follow approved study protocols.
• Oversee participant recruitment, screening, informed consent, and enrollment.
• Schedule and coordinate study visits, procedures, and sample collection.
• Manage and maintain accurate study documentation and regulatory files.
• Collect, process, code, and analyze clinical data; prepare reports for sponsors and investigators.

Regulatory & Compliance

• Ensure compliance with Institutional Review Boards (IRB), FDA, and other regulations governing human subject research.
• Prepare and submit regulatory documents, amendments, and safety reports.
• Participate in internal and external audits, quality assurance, and monitoring visits.

Protocol Development & Research Support

• Contribute to new protocol development and implementation planning.
• Support preparation of research manuscripts, reports, and grant proposals
• Communicate with investigators, clinical staff, sponsors, and external partners.

High School Diploma or equivalent and SoCRA certification and 6 years of clinical research experience or Bachelor’s degree and 2 years of clinical research experience or Master’s Degree and 1 year clinical research experience.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

925 Chestnut Street, Philadelphia, Pennsylvania, United States of America

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.