Regulatory Coordinator, Clinical Research

Cenexelresearch; Gaithersburg, Northern (MD, KY); Hybrid; 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 seeks an entry-level Regulatory Affairs professional to organize and implement regulatory documents for FDA-guided clinical trials. You will maintain regulatory files, prepare submissions, and coordinate training per SOPs with IRB interfaces.

Responsibilities include collecting sponsor documents, managing licenses and logs, and serving as a regulatory resource for the team; 0-2 years’ experience and proficiency in Excel/Word are required.

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 provide regulatory support efficiently and effectively for multiple trials.
• Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.
• Must be self-directed and able to manage multiple projects and responsibilities.

Responsibilities

• Collect, prepare, and submit startup documents to sponsors/CROs.
• Collect, prepare, and submit documentation to IRBs for trials.
• Serve as a liaison between the IRB, site, and investigators.
• Obtain necessary signatures from investigators.
• Coordinate contracts with third-party vendors.
• Maintain and track staff credentials and training.

Skills

Regulatory affairs

Attention to detail

Organization

Verbal and written communication

Excel

Word

Team collaboration

Time management

Tools

Excel

Word

Job description

CenExel CBH in Gaithersburg, MD seeks an entry-level Regulatory Affairs professional to organize and implement regulatory documents for FDA-guided clinical trials. You will maintain regulatory files, prepare submissions, and coordinate training per SOPs with IRB interfaces.

Responsibilities include collecting sponsor documents, managing licenses and logs, and serving as a regulatory resource for the team; 0-2 years’ experience and proficiency in Excel/Word are required.