Job DescriptionThe Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies.
Serving within an Academic CRO and Data and Clinical Coordinating Center environment, this position is responsible for regulatory oversight of domestic and international multicenter clinical trials conducted across participating research institutions. The Director provides leadership for regulatory affairs and safety operations activities across the study lifecycle, and ongoing support of participating sites within multicenter clinical research networks.
The ideal candidate will have demonstrated experience with FDA and Health Canada submissions, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, Institutional Review Board (IRB) submissions (sIRB and local IRB), and regulatory oversight of multi-center human subjects research.
ResponsibilitiesRegulatory & Compliance- Provide strategic leadership including development and oversight of regulatory activities supporting multicenter clinical trials
- Ensure sponsor and multi-center site compliance with FDA regulations, ICH-GCP guidelines, human subjects protection requirements, institutional policies, sponsor obligations, and applicable international regulatory requirements including Canada, the United Kingdom, and the European Union for IND, IDE, and non-FDA regulated clinical trials
- Ensure compliance with applicable international privacy and data protection requirements, including GDPR and related regulations
- Develop and implement regulatory policies, procedures, and operational processes that support compliant and efficient research operations including creation of regulatory document and binder templates, Manuals of Procedures (MOPs) and SOPs
- Prepare and submit new study applications (IND/IDE), amendments, continuing reviews, reportable safety events, and study closures to the FDA, HC, and Institutional Review Boards
- Monitor regulatory deadlines and reporting requirements to ensure ongoing compliance at both the DCC/CCC and study site level
- Develop and maintain regulatory binders (including oversight of study site regulatory binders) and essential study documents including Trial Master File (eTMF)
- Create and review informed consent document templates and recruitment materials for regulatory compliance and consistency with protocol requirements
- Track protocol amendments, investigator qualifications, training records, and regulatory approvals for the DCC/CCC and the study staff at participating sites
- Support study start-up, staff and study team training, site activation, audits, and inspections
- Assist with responses to regulatory findings, audit observations, and corrective and preventive action (CAPA) plans when needed
- Ensure ongoing readiness for sponsor audits, quality assurance reviews, and regulatory inspections
- Direct, train, and mentor regulatory, safety, and administrative personnel
Safety Operations & Oversight Committees- Provide leadership and oversight for clinical trial safety operations, including expedited safety reporting, and other regulatory safety requirements for IND/IDE/non-FDA regulated clinical trials
- Oversee safety desk operations and ensure timely communication of safety information to investigators, sponsors, IRBs, DSMBs, regulatory authorities, and participating sites
- Oversee operational and regulatory support for Data and Safety Monitoring Boards (DSMBs), Clinical Event Adjudication Committees (CEC/EACs), Independent Medical Monitors, and other required parties
Qualifications- Bachelors Degree in Administration, or related field Masters preferred
- 7 years experience in administration
- Previous experience in IRB
- IRB Certification preferred
Preferred:- Advanced degree (Master's or higher) in Life Sciences, Regulatory Affairs, Health Administration, or a related field or Bachelor's degree with equivalent experience
- Minimum of seven (7) years of progressively responsible experience in clinical research regulatory affairs supporting multicenter clinical research studies as described above
- Minimum of three (3) years of leadership experience managing regulatory affairs and safety operations related personnel
- Demonstrated experience supporting FDA-regulated clinical trials, including IND and/or IDE studies
- Strong knowledge of FDA regulations, ICH-GCP guidelines, human subjects protections, informed consent requirements, IRB processes, and clinical trial regulatory documentation and compliance requirements
- Experience with applicable submissions to the FDA, IRB, HC, and other regulatory bodies as required
- Excellent leadership, organizational, interpersonal and communication skills supporting collaboration with investigators, sponsors, regulatory authorities, participating institutions, oversight committees, and multidisciplinary teams
- Ability to manage multiple studies and competing deadlines in a fast-paced environment.
- Exceptional attention to detail and documentation practices.
- Proficiency with Microsoft Office applications, version control of critical documents, and electronic regulatory management systems.
- Regulatory Affairs Certification (RAC) or Certified Clinical Research Professional (CCRP/CCRC) certification
- Knowledge of European Union Clinical Trials Regulation (CTR), GDPR, United Kingdom data protection requirements
- Experience supporting multicenter clinical research networks, or similar coordinating center environments in a CRO, ARO, or sponsor environment
- Experience with FDA inspections and sponsor audits
