Regulatory Specialist

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

🚫👨‍🎓 No degree required

👻 Ghost score 12%

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Logo of Centricity Research

Centricity Research

201 - 500 employees

🏥 Healthcare

💊 Pharmaceuticals

🤝 B2B

Healthcare • Pharmaceuticals • B2B

Centricity Research is one of the largest clinical research site networks in North America, operating sites across the United States and Canada. The organization recruits and manages participants for clinical trials, advertises paid study participation, and supports sponsors and CROs in bringing new medicines to market. Public materials state Centricity has completed 3,500+ studies across 35+ therapeutic areas, served 25,000+ patients, and been involved with 100+ FDA & Health Canada drug approvals; it also expands via acquisitions (for example, Lucas Research).

📋 Description

• Prepare and submit required regulatory documents for study start-up and ongoing maintenance • Liaise with sponsors, CROs, and ethics committees (REB/IRB) to facilitate review and approval of study documents • Maintain central regulatory files, including CVs, licenses, certifications, and other essential documents • Track expiration dates and proactively update required documents • Support site staff and Clinical Research Coordinators with documentation requests, continuing review, and study close-out submissions • Coordinate with Budgets & Contracts, Business Development, and Recruitment teams on study start-up and recruitment material submissions • Manage essential documents requiring signatures, including distribution, tracking, and archiving • Assist with feasibility tracking and provide metrics to sponsors and senior management • Maintain accurate and complete documentation for audit and inspection readiness

🎯 Requirements

• 1–3 years of clinical research experience, preferably in regulatory or quality assurance • Solid understanding of ICH/GCP, FDA, Health Canada, and ethics committee requirements • Highly organized and able to manage multiple priorities while meeting deadlines • Clear and effective communication with internal teams, sponsors, CROs, and regulatory bodies • Detail-oriented and proactive in identifying and resolving documentation or compliance issues • Comfortable working independently and collaboratively in a fast-paced environment • Experience with CTMS, EDC, or other document management systems

🏖️ Benefits

• Comprehensive health, dental, and vision insurance • Enhanced EAP – mental health support • Flexible PTO + paid holidays • Continuing education reimbursement • 401(k) / RRSP with company match and immediate vesting

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