Regulatory Coordinator — Clinical Trials & Compliance

CenExel; 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 Clinical Research in Gaithersburg, MD is seeking a Regulatory Affairs Coordinator to organize and implement regulatory documents for FDA-guided trials, ICH GCP adherence, and SOP-compliant processes. Manage start-up documents, IRB submissions, and trainer staff on SOPs.

You will maintain regulatory documents, coordinate with sponsors, and ensure study teams stay compliant. This role emphasizes attention to detail, multi-tasking across trials, and strong communication.

Qualifications

• 0-2 years of experience in clinical research regulatory affairs.
• Knowledge of good clinical practices (GCP) as defined by CFR.
• Demonstrated organizational skills to support multiple trials and projects.
• Ability to prioritize workload to meet PI, coordinators, sponsors, and IRBs.
• Strong written and verbal communication abilities.
• Proficient in Excel and Word for data entry and correspondence.

Responsibilities

• Collect, prepare, and submit documentation to sponsors/CROs during study start-up.
• Submit documents/approvals, protocol amendments, informed consent forms, FDA 1572, and logs.
• Collect, prepare, and submit documentation to IRBs for ongoing and new trials.
• Serve as a liaison between IRB, site, and investigator; obtain signatures.
• Coordinate contracts with third-party vendors and manage staff credentials.
• Provide regulatory guidance and training on SOPs across staff.

Skills

GCP knowledge

Regulatory affairs

Organizational skills

Multi-project management

Communication skills

Excel & Word

Interpersonal skills

Prioritization

Clinical trials know-how

Tools

Excel

Word

Job description

CenExel Clinical Research in Gaithersburg, MD is seeking a Regulatory Affairs Coordinator to organize and implement regulatory documents for FDA-guided trials, ICH GCP adherence, and SOP-compliant processes. Manage start-up documents, IRB submissions, and trainer staff on SOPs.

You will maintain regulatory documents, coordinate with sponsors, and ensure study teams stay compliant. This role emphasizes attention to detail, multi-tasking across trials, and strong communication.