Regulatory Specialist
hace 3 días
Toms River
Job Description Overview The Regulatory Specialist supports the regulatory management of clinical research studies from study start-up through close-out and archiving. This role prepares, maintains, tracks, and files essential regulatory documents; coordinates submissions and approvals with Sponsors, CROs, and IRBs; maintains accurate electronic regulatory records; supports monitoring visits and study close-out; and helps ensure site activities remain consistent with applicable regulations, Good Clinical Practice (GCP), study protocols, Sponsor requirements, and PhaseWell Research SOPs. The Regulatory Specialist partners closely with Principal Investigators, Sub-investigators, Clinical Operations, Clinical Research Coordinators, Quality Assurance, Patient Recruitment, Business Development, Marketing, Contracts/Finance, and external study partners to support compliant, inspection-ready study conduct. Key Responsibilities Study Start-Up & Regulatory Submissions • Receive and organize regulatory packages for new studies and maintain accurate study start-up tracking., • Coordinate and participate in study start-up meetings to ensure stakeholder alignment on regulatory deliverables and timelines., • Prepare, complete, route, and maintain required regulatory documents, including Form FDA 1572s, financial disclosures, delegation logs, investigator/sub-investigator CVs and licenses, study-level informed consent forms, IRB questionnaires, and applicable authorization forms., • Coordinate submission of recruitment and advertising materials for IRB approval in partnership with appropriate stakeholders., • Track regulatory documentation submission status, approvals, expiration dates, and required follow-up actions; communicate approvals and regulatory updates to relevant site personnel., • Ensure final, signed, and approved documents are promptly filed in the appropriate Investigator Site File. Regulatory Maintenance & Compliance • Maintain complete, accurate, current, and inspection-ready Investigator Site Files throughout the study lifecycle., • Ensure that study team changes are quickly and appropriately reflected in the regulatory documentation (e.g., FDA 1572 updated when there is an investigator change)., • Monitor investigator and study-team credentials, including CVs, medical licenses, training documentation, delegation logs, and related records. Request to receive updated documentation when needed., • Obtain PI signatures on IND safety reports, and other applicable safety/regulatory communications, in accordance with Sponsor requirements and PhaseWell Research SOPs and ensure that these documents are promptly filed in the appropriate Investigator Site Files., • Process and file protocol amendments, Investigator's Brochure updates, revised recruitment materials, revised informed consent forms, and other updated study-specific regulatory documents., • Create and maintain regulatory memos-to-file when appropriate. Ensure that the memos ‘tell the story’ completely and clearly, and that they are appropriately dated and traceable., • Protect confidentiality, integrity, version control, and accessibility of regulatory records and study information. Monitoring/Auditing/Inspection Readiness, Close-Out & Archiving • Prepare regulatory files and support documentation for Sponsor monitoring visits and audits, internal audits, and Regulatory Inspections. Partner with Clinical Research Coordinators and study teams to facilitate timely resolution of regulatory document requests., • Support study close-out activities and ensure required regulatory documentation is complete before archiving., • Manage the archiving of closed-study records, including source, regulatory, and eCRF records, in accordance with applicable PhaseWell Research SOPs and Sponsor requirements., • Coordinate sponsor notifications and return/destruction of archived records only when permitted by the sponsor-specific Clinical Trial Agreement and PhaseWell Research SOPs. Systems, Data Integrity & Cross-Functional Partnership • Maintain accurate study information and regulatory documentation in the site’s Regulatory platform (if applicable)., • Ensure regulatory documents are complete, accurate, current, appropriately filed, and readily retrievable. Conduct and document routine Quality Control checks on regulatory documentation and any associated trackers., • Work effectively with Principal Investigators, Sub-Investigators, Clinical Operations, Clinical Research Coordinators, Quality Assurance, Patient Recruitment, Business Development, Marketing, Finance/Contracts, and Sponsor representatives., • Escalate missing documentation, compliance concerns, overdue actions, or other regulatory risks promptly to the appropriate leader., • Support continuous improvement of regulatory processes, documentation practices, and study start-up workflows., • Remain current on, and comply with, all regulations, GCPs, sponsor requirements, and SOPs, as they relate to regulatory documentation., • Provide guidance to study team members, and other company employees, regarding compliance with regulations, GCPs, sponsor requirements, and SOPs, as they relate to regulatory documentation., • Assist with the development and implementation of departmental training programs, including the creation of any associated employee knowledge assessments., • Assist with the assessment and management of company vendors (those that are hired to provide PhaseWell with goods and services that are related to regulatory documentation) to ensure that they consistently meet regulatory requirements and PhaseWell Quality standards., • May assist with sponsor audits and/or regulatory authority inspections (including preparation, participation, and follow-up) in accordance with company procedures., • Assist in the training and/or mentoring of other Regulatory department staff., • Perform additional duties as assigned. Qualifications • Bachelor's degree (or equivalent relevant experience) in Business Administration, Communications, Clinical Research, Healthcare Administration, or a related field., • 2–4 years of experience in clinical research, regulatory affairs, research administration, or a related healthcare/research environment; site-level clinical research experience preferred., • Working knowledge of FDA regulations, ICH Guidelines, HIPAA, and other Good Clinical Practices., • Familiarity with FDA Form 1572, investigator qualifications, delegation documentation, financial disclosures, informed consent documentation, safety reporting, protocol amendments, and IRB submissions., • Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, Teams, and SharePoint; experience with electronic regulatory systems and clinical trial software preferred., • Strong attention to detail and demonstrated ability to maintain accurate, complete, and inspection-ready documentation., • Excellent written and verbal communication skills, with the ability to work effectively with investigators, clinical teams, Sponsors, CROs, IRBs, and other stakeholders., • Strong organizational and time-management skills with the ability to manage multiple studies, deadlines, and competing priorities., • Ability to maintain strict confidentiality of patient, employee, Sponsor, financial, and study information., • Ability to work independently while exercising sound judgment about when to ask questions and when to escalate regulatory or compliance issues., • Professionalism/professional standards (tactful, punctual, dedicated, reliable, trustworthy, ethical, etc.) Location • On-Site Monday-Friday Cultural Values Fit • Patients First — Protects participant rights, safety, dignity, and confidentiality by supporting compliant, high-quality clinical research and maintaining accurate regulatory records., • Hustle Harder — Takes ownership of regulatory deliverables, follows through on commitments, anticipates deadlines, and moves quickly to resolve documentation gaps and study start-up needs., • Authenticity, Always — Communicates openly and accurately, raises concerns promptly, and builds trust through transparency, accountability, and professionalism., • Serve with Joy — Brings a collaborative, service-oriented approach to supporting investigators, clinical teams, Sponsors, CROs, and colleagues; welcomes feedback and contributes to a positive team environment., • Excellence Together — Pursues high standards in regulatory compliance, documentation, data integrity, and inspection readiness while partnering across functions to deliver consistent, compliant study execution. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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