Regulatory Document Specialist

Part-Time Remote Regulatory Document Specialist Position: Part-Time Remote Regulatory Document SpecialistHours: 20 hours per weekWe need someone who knows how to manage regulatory documents and maintain a clean and organized eISF!CRIO experience necessary.Oncology experience highly preferred.ResponsibilitiesMaintain and organize the Investigator Site File (ISF) for all active and archived clinical trials in accordance with ICH E6(R3) GCP guidelinesManage and maintain site regulatory documents within the CRIO eRegulatory platform, ensuring all records are current, complete, and inspection-ready at all timesCollect, track, and file essential regulatory documents including FDA Forms 1572, financial disclosure forms, protocol amendments, IRB approvals, and sponsor correspondence — all managed remotely via electronic platformsCoordinate with the IRB for initial submissions, continuing reviews, amendments, and safety reports; track submission and approval deadlines independentlyObtain and maintain current CVs, medical licenses, and training records (GCP, CITI, protocol-specific) for all site personnel listed on study protocolsTrack expiration dates for time-sensitive documents (IRB approvals, licenses, delegations of authority) and proactively initiate renewals without on-site promptingPrepare regulatory document packages for sponsor/CRO monitoring visits (remote and on-site) and support monitors with eRegulatory platform access and document retrievalRespond to regulatory document requests from monitors during remote monitoring visits; resolve regulatory findings in a timely manner with clear electronic communicationCommunicate regularly with on-site study staff, the Principal Investigator, and sponsor/CRO representatives via email, phone, and video conference to ensure document accuracy and completenessAssist with preparation for FDA inspections and ensure the site maintains audit-readiness standards at all times from a remote capacityAdditional Skills & QualificationsPrior experience in clinical research regulatory document managementHands-on experience with an eRegulatory platform; CRIO experience strongly preferredDemonstrated ability to work effectively and independently in a fully remote environment with minimal supervisionAbility to manage and prioritize workload efficiently within a 20-hour-per-week schedule across multiple active studiesReliable high-speed internet connection and a dedicated, distraction-free home workspaceStrong virtual communication skills — responsive, professional, and proactive in keeping on-site staff informedWorking knowledge of ICH E6(R3) GCP guidelines, FDA regulations, and IRB submission processesProficiency with Microsoft Office Suite, video conferencing tools (Zoom, Teams), and web-based document management platformsStrong attention to detail and organizational skills with the ability to manage multiple studies simultaneously without on-site oversightCurrent GCP certification (CITI or equivalent) preferred, or willingness to obtain upon hireAssociate's or Bachelor's degree in a health-related, life sciences, or administrative field preferred; equivalent experience consideredACRP or SOCRA certification (CCRC, CCRP) a plusJob Type & LocationThis is a Contract position based out of Albuquerque, NM.Pay and BenefitsThe pay range for this position is $35.00 - $45.00/hr.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully remote position.Application DeadlineThis position is anticipated to close on Jun 15, 2026.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.