{"id":4095276,"url":"https://alion.io/job/phasewell-regulatory-specialist","title":"Regulatory Specialist","company":{"id":4420222,"name":"PhaseWell","domain":"phasewell.com","url":"https://alion.io/company/phasewell","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Toms River, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"HIPAA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-11-11T16:20:10Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-11T20:59:41Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Description\nOverview\nThe 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.\nKey Responsibilities\nStudy Start-Up & Regulatory Submissions\nReceive and organize regulatory packages for new studies and maintain accurate study start-up tracking. \nCoordinate and participate in study start-up meetings to ensure stakeholder alignment on regulatory deliverables and timelines. \nPrepare, 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. \nCoordinate submission of recruitment and advertising materials for IRB approval in partnership with appropriate stakeholders. \nTrack regulatory documentation submission status, approvals, expiration dates, and required follow-up actions; communicate approvals and regulatory updates to relevant site personnel. \nEnsure final, signed, and approved documents are promptly filed in the appropriate Investigator Site File. \nRegulatory Maintenance & Compliance\nMaintain complete, accurate, current, and inspection-ready Investigator Site Files throughout the study lifecycle. \nEnsure that study team changes are quickly and appropriately reflected in the regulatory documentation (e.g., FDA 1572 updated when there is an investigator change). \nMonitor investigator and study-team credentials, including CVs, medical licenses, training documentation, delegation logs, and related records. Request to receive updated documentation when needed. \nObtain 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. \nProcess and file protocol amendments, Investigator's Brochure updates, revised recruitment materials, revised informed consent forms, and other updated study-specific regulatory documents. \nCreate 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. \nProtect confidentiality, integrity, version control, and accessibility of regulatory records and study information. \nMonitoring/Auditing/Inspection Readiness, Close-Out & Archiving\nPrepare 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. \nSupport study close-out activities and ensure required regulatory documentation is complete before archiving. \nManage the archiving of closed-study records, including source, regulatory, and eCRF records, in accordance with applicable PhaseWell Research SOPs and Sponsor requirements. \nCoordinate sponsor notifications and return/destruction of archived records only when permitted by the sponsor-specific Clinical Trial Agreement and PhaseWell Research SOPs. \nSystems, Data Integrity & Cross-Functional Partnership\nMaintain accurate study information and regulatory documentation in the site’s Regulatory platform (if applicable). \nEnsure 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. \nWork effectively with Principal Investigators, Sub-Investigators, Clinical Operations, Clinical Research Coordinators, Quality Assurance, Patient Recruitment, Business Development, Marketing, Finance/Contracts, and Sponsor representatives. \nEscalate missing documentation, compliance concerns, overdue actions, or other regulatory risks promptly to the appropriate leader. \nSupport continuous improvement of regulatory processes, documentation practices, and study start-up workflows. \nRemain current on, and comply with, all regulations, GCPs, sponsor requirements, and SOPs, as they relate to regulatory documentation. \nProvide guidance to study team members, and other company employees, regarding compliance with regulations, GCPs, sponsor requirements, and SOPs, as they relate to regulatory documentation. \nAssist with the development and implementation of departmental training programs, including the creation of any associated employee knowledge assessments. \nAssist 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. \nMay assist with sponsor audits and/or regulatory authority inspections (including preparation, participation, and follow-up) in accordance with company procedures. \nAssist in the training and/or mentoring of other Regulatory department staff. \nPerform additional duties as assigned. \nQualifications\nBachelor's degree (or equivalent relevant experience) in Business Administration, Communications, Clinical Research, Healthcare Administration, or a related field. \n2-4 years of experience in clinical research, regulatory affairs, research administration, or a related healthcare/research environment; site-level clinical research experience preferred. \nWorking knowledge of FDA regulations, ICH Guidelines, HIPAA, and other Good Clinical Practices. \nFamiliarity with FDA Form 1572, investigator qualifications, delegation documentation, financial disclosures, informed consent documentation, safety reporting, protocol amendments, and IRB submissions. \nProficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, Teams, and SharePoint; experience with electronic regulatory systems and clinical trial software preferred. \nStrong attention to detail and demonstrated ability to maintain accurate, complete, and inspection-ready documentation. \nExcellent written and verbal communication skills, with the ability to work effectively with investigators, clinical teams, Sponsors, CROs, IRBs, and other stakeholders. \nStrong organizational and time-management skills with the ability to manage multiple studies, deadlines, and competing priorities. \nAbility to maintain strict confidentiality of patient, employee, Sponsor, financial, and study information. \nAbility to work independently while exercising sound judgment about when to ask questions and when to escalate regulatory or compliance issues. \nProfessionalism/professional standards (tactful, punctual, dedicated, reliable, trustworthy, ethical, etc.) \nLocation\nOn-Site Monday-Friday \nCultural Values Fit\nPatients First - Protects participant rights, safety, dignity, and confidentiality by supporting compliant, high-quality clinical research and maintaining accurate regulatory records. \nHustle Harder - Takes ownership of regulatory deliverables, follows through on commitments, anticipates deadlines, and moves quickly to resolve documentation gaps and study start-up needs. \nAuthenticity, Always - Communicates openly and accurately, raises concerns promptly, and builds trust through transparency, accountability, and professionalism. \nServe 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. \nExcellence Together - Pursues high standards in regulatory compliance, documentation, data integrity, and inspection readiness while partnering across functions to deliver consistent, compliant study execution. \nOther Duties\nPlease 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. 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