Clinical Research Coordinator II – Surgical Services

About the role

The Clinical Research Coordinator II (CRC II) leads coordination of multiple surgical and transplant research studies at Georgetown University Medical Center. Reporting to the Assistant Research Manager and collaborating with a Research Director, the CRC II ensures smooth implementation of complex clinical trials.

Key responsibilities

• Manage a portfolio of surgical and transplant studies, including General Surgery, Burn, Breast, Endocrine, Trauma, Colorectal, and Surgical Oncology.
• Prepare and submit regulatory documents, maintain study files, and ensure compliance with FDA, OHRP, and ICH GCP guidelines.
• Screen, enroll, and monitor participants, handling data abstraction, entry, and management.
• Coordinate study budgets, contracts, and Medicare Coverage Analysis (MCA) for billing compliance.
• Serve as primary contact for sponsors, CROs, and IRBs, and support on‑call research rotation.

Required profile

• Bachelor’s degree in a scientific or related field.
• At least 3 years of clinical research coordination experience (CRC I or equivalent).
• Strong organizational, critical‑thinking, and problem‑solving abilities.

Required skills

• Working knowledge of FDA regulations and OHRP requirements.
• Familiarity with ICH Good Clinical Practice (GCP) guidelines.
• Experience with clinical trial contracting, budgeting, and Medicare Coverage Analysis.
• Proficiency in clinical trials data management and documentation.