Clinical Research Regulatory Specialist

Job description

**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: - A culture of respect, transparency, and continuous improvement - Opportunities for professional growth and learning - A team dedicated to improving lives through innovation and integrity 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** - Distribute IRB approvals, amendments, and ICF updates, and verify that site staff are informed before study activities proceed. - Submit continuing reviews, protocol deviations, and other required reports to the IRB within established timelines. - Maintain version control so only current, approved ICFs and study documents are in use. **Staff Credentialing & Delegation** - Complete regulatory onboarding for new staff, including Form FDA 1572 updates, training logs, financial disclosure forms, and delegation of authority log entries. - Track licenses, certifications, and training expirations, and prompt renewals before they lapse. **Audit Readiness & Sponsor Support** - Maintain regulatory binders and study files in CRIO eReg in a state of continuous audit readiness. - Resolve sponsor and CRA action items from monitoring visits, and respond to document requests, within established timelines. **Study Closeout** - Submit IRB termination reports, end staff delegation, and complete closeout documentation. - Coordinate records retention and archiving. **Cross-Site Team Collaboration** - Partner with the central start-up team for a smooth handoff at study activation. - Participate in twice-weekly check-ins and monthly regulatory team meetings to share updates and best practices. **Job Requirements:** - Bachelor's degree in life sciences, clinical research, or a related field. - 1-2 years of clinical trial experience; regulatory experience preferred. - Working knowledge of GCP and IRB processes; familiarity with FDA regulations and 21 CFR Part 11 preferred. - Experience with eReg or eSource systems preferred (CRIO a plus). - Strong written and verbal communication skills with PIs, sponsors, CROs, and site teams. - Collaborative and respectful, with a kind, patient approach to working with site staff and colleagues, including under tight deadlines. - Results-driven, taking ownership, following through, and adapting as priorities shift. - Detail-oriented and thorough, catching discrepancies such as outdated ICF versions and confirming documents are filed and communicated to the right people. **Pay:** $60-75k salary, commensurate with experience **Benefits**: - 401(k) matching - Medical, Dental, & Vision insurance - Employee assistance program - Flexible spending account - Health insurance - Health savings account - Life insurance - Paid time off - Parental leave - Professional development assistance 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.