The Regulatory Compliance Manager will support the Executive Director for the Center of Excellence for Clinical & Translational Research in the planning, execution, and coordination of regulatory activities associated with clinical research projects conducted by the Organization. Responsibilities include supporting regulatory submissions, maintaining essential regulatory documentation, and ensuring compliance with study protocols, International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines, U.S. Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) requirements, the Common Rule (45 CFR 46), HIPAA, applicable federal and state regulations, and organizational policies and procedures.
Essential Functions (Principal Duties and Job Responsibilities):
- Prepare, compile, maintain, and support submissions related to INDs, IDEs, protocol amendments, continuing reviews, annual reports, safety reports, and other regulatory filings under the guidance of The Executive Director for the Center of Excellence for Clinical & Translational Research.< >Maintain regulatory binders, electronic regulatory files, investigator/site regulatory records, and essential documents, including investigator qualifications, training records, financial disclosures, delegation logs, laboratory certifications, and other required documentation in accordance with ICH-GCP and organizational SOPs.
- Review regulatory documents for completeness, consistency, and accuracy, and collaborate with project team members to ensure submission requirements are met.
- Serve as a regulatory contact for study sponsors, IRBs, regulatory agencies, and other oversight bodies, as applicable.
- Support IRB submissions, continuing reviews, amendments, reportable events, and study closure activities.< >Monitor updates from the FDA, Office for Human Research Protections (OHRP), IRBs, ClinicalTrials.gov, and other applicable regulatory authorities to ensure ongoing compliance with current regulations, guidance documents, and industry standards. Support clinical trial registration and results reporting activities in ClinicalTrials.gov, as applicable.
- Support communications and submissions to the FDA under the direction of Regulatory Affairs leadership when required.
- Provide guidance and support to study teams regarding regulatory requirements, processes, and documentation.< >Identify project needs, track timelines, and manage day-to-day workload in collaboration with the Executive Director for the Center of Excellence for Clinical & Translational Research.
- Provide regulatory support to the Safety Team and assist with the preparation, tracking, and submission of serious adverse event reports, safety reports, and other pharmacovigilance-related documentation in accordance with organizational SOPs and sponsor requirements.
- Assist with preparation for sponsor, regulatory authority, and internal audits and inspections, including documentation review and response activities.< >Follow organizational SOPs and procedural documents consistently and contribute to process improvement initiatives.
- Perform other duties as assigned.
Knowledge, Skills and Abilities Required:
- Effective oral and written communication skills in English
- Excellent interpersonal skills
- Uncompromising attention to detail and the ability to think analytically
- Organization and planning ability
- Sound problem-solving and decision-making skills
- Medical/therapeutic area knowledge and medical terminology
- High level of interpersonal awareness and diplomacy
- Strong knowledge of clinical research regulations and guidelines, including FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812, and applicable sections of 814), ICH-GCP, HIPAA, and 45 CFR 46 (Common Rule).
- Experience with an institutional review board (IRB) and/or human subjects’ research
- Experience writing, reviewing, developing, or implementing policies, processes, and procedures
- Proficiency in Microsoft Office Suite and the ability to learn and effectively utilize regulatory and clinical research software systems.
- The ability to work unsupervised / independently on several projects.
Knowledge, Skills, Abilities Preferred:
- A minimum of two (2) years of experience in clinical research, pharmaceutical, biotechnology, academic medical center, or healthcare setting is preferred. Experience preparing, maintaining, and managing regulatory documentation and submissions in support of clinical research studies is preferred.
Education and Experience Required:
- Bachelor's degree in life sciences, health sciences, nursing, pharmacy, public health, regulatory affairs, or related field required.
Education and Experience Preferred:
- Advanced degree (MS, MPH, PharmD, or equivalent) preferred.
Licensure, Certification or Registration Required:
- Current certification in Good Clinical Practice (GCP) training (or ability to obtain within 90 days of hire).
- Current Human Subjects Protection (HSP) training (e.g., CITI Program or equivalent) or ability to obtain within 90 days of hire.
- Must maintain all required institutional, sponsor, and regulatory training throughout employment.
Licensure, Certification or Registration Preferred:
- Certified Clinical Research Professional (CCRP) – Society of Clinical Research Associates (SOCRA)
- Certified Clinical Research Coordinator (CCRC) – Association of Clinical Research Professionals (ACRP)
- Regulatory Affairs Certification (RAC) – Regulatory Affairs Professionals Society (RAPS)
- Demonstrated knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812), ICH E6(R3) Good Clinical Practice, HIPAA, and applicable federal regulations governing human subjects research.
