Clinical Research Coordinator: Impactful Study Operations

Colonial Group; Oxon Hill (MD); On-site; USD 60,000 - 85,000; Full time

Job summary

Colonial Group is seeking a Clinical Research Coordinator (CRC) to support daily clinical trial activities under the supervision of the Principal Investigator. The role involves coordinating with the PI, department, and sponsor to ensure compliance with federal regulations and timelines.

The CRC will assist with feasibility assessments, protocol reviews, and the preparation of regulatory documents, informed consent, and source data. Strong attention to detail and confidentiality are essential.

Qualifications

• Bachelor's degree preferred.
• CRC/CRP certification preferred.
• GCP training preferred.
• IATA training preferred.

Responsibilities

• Coordinate with PI, department, and administration to ensure research activities comply with Federal Regulations and sponsor policies.
• Assist PI with study feasibility assessments as requested.
• Review study protocol and attend investigator meetings.
• Prepare regulatory submissions and study materials (consent forms, source docs, enrollment logs).
• Develop and maintain study files and regulatory binders.
• Explain protocol requirements to study staff and provide training with logs.
• Gather documents for sponsor submission (e.g., FDA Forms 1572, CVs).
• Support recruitment strategies and IRB communications.

Skills

Regulatory compliance

Time management

Communication

HIPAA/privacy

Ethics & professionalism

Team collaboration

Documentation

Problem solving

Education

Bachelor's degree in related field

CRC/CRP certification (SoCRA/ACRP)

GCP certification

Phlebotomy certification (preferred)

Tools

IRB/Regulatory submissions

Job description

Colonial Group is seeking a Clinical Research Coordinator (CRC) to support daily clinical trial activities under the supervision of the Principal Investigator. The role involves coordinating with the PI, department, and sponsor to ensure compliance with federal regulations and timelines.

The CRC will assist with feasibility assessments, protocol reviews, and the preparation of regulatory documents, informed consent, and source data. Strong attention to detail and confidentiality are essential.