Regulatory Document Specialist

Description Position:

Part-Time Remote Regulatory Document Specialist Hours:

20 hours per week We need someone who knows how to manage regulatory documents and maintain a clean and organized eISF! CRIO experience necessary. Oncology experience highly preferred. Responsibilities

• Maintain and organize the Investigator Site File (ISF) for all active and archived clinical trials in accordance with ICH E6(R3) GCP guidelines
• Manage and maintain site regulatory documents within the CRIO eRegulatory platform, ensuring all records are current, complete, and inspection-ready at all times
• Collect, 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 platforms
• Coordinate with the IRB for initial submissions, continuing reviews, amendments, and safety reports; track submission and approval deadlines independently
• Obtain and maintain current CVs, medical licenses, and training records (GCP, CITI, protocol-specific) for all site personnel listed on study protocols
• Track expiration dates for time-sensitive documents (IRB approvals, licenses, delegations of authority) and proactively initiate renewals without on-site prompting
• Prepare regulatory document packages for sponsor/CRO monitoring visits (remote and on-site) and support monitors with eRegulatory platform access and document retrieval
• Respond to regulatory document requests from monitors during remote monitoring visits; resolve regulatory findings in a timely manner with clear electronic communication
• Communicate regularly with on-site study staff, the Principal Investigator, and sponsor/CRO representatives via email, phone, and video conference to ensure document accuracy and completeness
• Assist with preparation for FDA inspections and ensure the site maintains audit-readiness standards at all times from a remote capacity Additional Skills & Qualifications Qualifications
• Prior experience in clinical research regulatory document management
• Hands-on experience with an eRegulatory platform; CRIO experience strongly preferred
• Demonstrated ability to work effectively and independently in a fully remote environment with minimal supervision
• Ability to manage and prioritize workload efficiently within a 20-hour-per-week schedule across multiple active studies
• Reliable high-speed internet connection and a dedicated, distraction-free home workspace
• Strong virtual communication skills — responsive, professional, and proactive in keeping on-site staff informed
• Working knowledge of ICH E6(R3) GCP guidelines, FDA regulations, and IRB submission processes
• Proficiency with Microsoft Office Suite, video conferencing tools (Zoom, Teams), and web-based document management platforms
• Strong attention to detail and organizational skills with the ability to manage multiple studies simultaneously without on-site oversight
• Current GCP certification (CITI or equivalent) preferred, or willingness to obtain upon hire
• Associate's or Bachelor's degree in a health-related, life sciences, or administrative field preferred; equivalent experience considered
• ACRP or SOCRA certification (CCRC, CCRP) a plus Job Type & Location This is a Contract position based out of Albuquerque, NM.

Pay and Benefits The 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 & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position.

Application Deadline This position is anticipated to close on Jun 15, 2026. About Actalent Actalent 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.