Clinical Research Regulatory Specialist
Required skills
- Regulatory Maintenance Specialist
- clinical trial site network
- data quality
- participant safety
- IRB approvals
- amendments
- staff credentialing
- delegation
- sponsor action items
- CRA action items
Nice to have
- eReg
- eSource systems
- CRIO
- 21 CFR Part 11
Role summary
Adams Clinical is seeking a Regulatory Maintenance Specialist for its Watertown site. This role is responsible for ensuring regulatory compliance and audit readiness for all active clinical trials from activation to closeout. Key duties include managing IRB approvals and amendments, maintaining staff credentials, resolving sponsor/CRA action items, and ensuring regulatory binders are up-to-date. The specialist will collaborate with site staff, PIs, sponsors, CRAs, and other regulatory colleagues across the network. This position requires a Bachelor's degree in a related field, 1-2 years of clinical trial experience with regulatory experience preferred, and working knowledge of GCP and IRB processes. Familiarity with FDA regulations and eReg systems is a plus. The role is onsite with potential for some remote work.
Join Us in Shaping the Future of Clinical Research
Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people make the difference. Guided by our core values—Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration—we create an environment where meaningful work drives meaningful change.
At Adams Clinical, you’ll find:
If you’re passionate about making an impact in clinical research and want to be part of a collaborative, mission-driven organization, we’d love to have you on our team.
Job Role
The Clinical Research Regulatory Specialist serves as the regulatory owner for the Watertown site, ensuring that every active study remains compliant and inspection ready from activation through closeout. This role combines hands on regulatory expertise with operational discipline, meticulous attention to detail, and close partnership with site operations to protect data quality and participant safety.
The Clinical Research Regulatory Specialist is responsible for managing IRB approvals and amendments, maintaining staff credentialing and delegation, resolving sponsor and CRA action items, and sustaining continuous audit readiness. Reporting to the Central Regulatory Maintenance Manager, this position partners with site staff, PIs, sponsors, and CRAs, and collaborates with regulatory colleagues across our six-site network. Supported by twice weekly team check ins, monthly regulatory meetings, and centralized study start up support, the role is measured against specific goals tied to performance bonuses. This is an onsite position with potential for a couple of work from home days.
Key Responsibilities:
IRB & Study Document Management
Staff Credentialing & Delegation
Audit Readiness & Sponsor Support
Study Closeout
Cross-Site Team Collaboration
Job Requirements:
Pay: $60-75k salary, commensurate with experience
Benefits:Adams Clinical is committed to being an equal opportunity and affirmative action employer. We focus on hiring and nurturing top talent. All employment decisions, including recruitment, hiring, promotion, compensation, transfer, training, discipline, and termination, are made based on the candidate’s or employee’s qualifications relevant to the position. These decisions are made without regard to age, sex, sexual orientation, gender identity or expression, genetic information, race, color, creed, religion, ethnicity, national origin, citizenship, disability, marital status, military status, pregnancy, or any other legally protected status.
In compliance with federal law, all individuals hired must, as a condition of employment, provide documentation verifying their identity and authorization to work in the United States and complete Form I-9 within the required time frame. Adams Clinical participates in E-Verify to confirm employment eligibility.
