Clinical Research Regulatory Coordinator - 246500

MedixChicago, IL, US

2 days ago

Job type

Permanent

Job description

Clinical Research Regulatory Coordinator Role - Chicago, IL (60611)

Job Summary :

The Clinical Research Regulatory Coordinator plays a vital role in ensuring the regulatory compliance of clinical trials from study start-up through closeout. This position is responsible for managing all aspects of regulatory documentation, submissions, and maintenance, while serving as a key liaison between investigators, sponsors, IRBs, and institutional stakeholders. The ideal candidate has a strong background in clinical research regulations and hands-on experience navigating complex regulatory requirements across multiple studies.

Key Responsibilities :

Coordinate the preparation, submission, and tracking of regulatory documents to IRBs, sponsors, and regulatory agencies, including new study applications, amendments, continuing reviews, and safety reports.
Maintain and organize regulatory files and documentation in compliance with institutional, FDA, and ICH-GCP requirements.
Ensure that all regulatory approvals are current and proactively manage expiration timelines for ongoing studies.
Serve as a primary point of contact for regulatory-related queries from internal teams, sponsors, and external partners.
Collaborate with study teams to support the start-up process and ensure timely activation of new trials.
Prepare for and support audits, monitoring visits, and inspections by providing accurate and up-to-date regulatory documentation.
Monitor changes in local and federal regulations and update processes accordingly.
Ensure that all study team members maintain appropriate certifications and training for research participation.

Qualifications :

Bachelor's degree in a health science, life science, or related field required.

2-3+ Years of Clinical Research Experience

In-depth knowledge of FDA regulations, ICH-GCP guidelines, and IRB procedures.

Strong attention to detail with excellent organizational and time-management skills.

Proficient in using electronic regulatory systems, IRB portals, and Microsoft Office applications.

Excellent written and verbal communication skills, with the ability to interact professionally with investigators, sponsors, and regulatory bodies.

Additional Details :

Title : Clinical Research Regulatory Coordinator

Location : Chicago, IL (60611)

Schedule : Monday-Friday; Normal Business Hours; Onsite 5 Days a week

Employment : ~6 month (1,040 Hours) contracted probationary period into direct hire / permanent position

Pay : $62,000-$95,000 (Dependent on background and years of experience)

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Clinical Research Coordinator • Chicago, IL, US