Clinical Regulatory Coordinator — Trials Compliance

CBH Health, LLC; Gaithersburg (MD); On-site; USD 37,000 - 41,000; Full time

Benefits offered by this job

Health Insurance

Dental

Vision

LTD

STD

Life Insurance

401k

Job summary

CenExel CBH in Gaithersburg, MD, is seeking a Regulatory Affairs Coordinator to organize and track regulatory documents for Phase I–IV trials, ensuring compliance with FDA guidelines, ICH GCP, and SOPs. The role supports start-up activities, ongoing submissions, and staff training.

The position requires 0–2 years in regulatory affairs, strong organizational and communication skills, and proficiency with Excel and Word. Compensation is $27–$30 per hour, with full benefits after 30 days.

Qualifications

• Knowledge of good clinical practices (GCP) per CFR.
• Ability to organize and support multiple trials efficiently.
• Strong communication and interpersonal skills for sponsors, IRBs, and staff.
• Ability to prioritize workload to meet PI and sponsor needs.

Responsibilities

• Collect, prepare, and submit trial documentation to sponsors/CROs during start-up.
• Coordinate with IRBs for ongoing and new trials; obtain signatures.
• Maintain regulatory documents and training records; ensure SOP adherence.
• Liaise between IRB, site, investigator; draft SOPs and SOP training as needed.
• Track and archive regulatory materials at study end and assist other staff with regulatory questions.

Skills

Regulatory affairs knowledge

FDA CFR knowledge

Organizational skills

Communication skills

Multi-project management

Tools

Excel

Word

Job description

CenExel CBH in Gaithersburg, MD, is seeking a Regulatory Affairs Coordinator to organize and track regulatory documents for Phase I–IV trials, ensuring compliance with FDA guidelines, ICH GCP, and SOPs. The role supports start-up activities, ongoing submissions, and staff training.

The position requires 0–2 years in regulatory affairs, strong organizational and communication skills, and proficiency with Excel and Word. Compensation is $27–$30 per hour, with full benefits after 30 days.