Senior Clinical Research Coordinator – Surgical Trials

Georgetown University; United States; On-site; USD 29,000 - 48,000; Full time

Job summary

Georgetown University is seeking a Clinical Research Coordinator II to lead coordination across several surgical research portfolios under the supervision of senior research leadership. The role emphasizes regulatory submissions, data management, participant screening and enrollment, and cross-team collaboration within the medical center environment.

The CRC II will contribute to on-call support for surgical and transplant services, ensuring compliance with ICH-GCP and FDA/OHRP guidelines, while

Qualifications

• Bachelor's degree in a scientific or related field with at least 3 years CRC I or equivalent clinical research experience.
• Knowledge of FDA, OHRP and ICH GCP guidelines.
• Strong organizational, critical thinking and problem-solving skills.
• Experience with clinical trials contracting and Medicare Coverage Analysis (MCA) and billing compliance.

Responsibilities

• Lead coordinator on multiple surgical services and possibly transplant clinical research studies under PI oversight.
• Handle regulatory submissions, data abstraction/entry/management.
• Screen and enroll study participants and manage overall study activities.
• Support research on-call rotation to assist with enrollments.

Skills

Interpersonal skills

Verbal communication

Written communication

Education

Bachelor's degree in a scientific or related field

3 years CRC I or equivalent clinical research experience

Tools

Microsoft Office

Google Workspace

EMR systems

Data capture systems

Job description

Georgetown University is seeking a Clinical Research Coordinator II to lead coordination across several surgical research portfolios under the supervision of senior research leadership. The role emphasizes regulatory submissions, data management, participant screening and enrollment, and cross-team collaboration within the medical center environment.

The CRC II will contribute to on-call support for surgical and transplant services, ensuring compliance with ICH-GCP and FDA/OHRP guidelines, while