Regulatory Coordinator

Job Title: Regulatory Affairs Coordinator (Source Document Creation)

The Regulatory Affairs Coordinator plays a key role in supporting dermatology industry-initiated clinical trials by developing, standardizing, and maintaining accurate source documentation across multiple studies. Working closely with Clinical Research Coordinators and the Regulatory Coordinator, this position ensures that all study records are complete, compliant, and audit-ready in alignment with GCP, FDA regulations, and study protocols. This role is ideal for a detail-oriented clinical research professional who thrives in a fast-paced, high-volume research environment and enjoys contributing directly to the quality and integrity of clinical trial data.

Responsibilities

• Create and standardize source document templates based on study protocols and sponsor requirements for dermatology industry-initiated clinical trials.
• Review study protocols, schedules of events, and case report forms (CRFs) to ensure that source documents capture all required data points.
• Maintain strict version control of source documents and implement updates promptly when protocols are amended.
• Perform ongoing quality checks to verify completeness, accuracy, and consistency between source data and entries in electronic data capture (EDC) systems.
• Identify gaps, discrepancies, or missing data in source documentation and collaborate with Clinical Research Coordinators (CRCs) to resolve issues promptly.
• Support the Regulatory Coordinator by ensuring that all source documentation is inspection-ready and aligned with regulatory expectations.
• Assist with building and organizing source documents during study start-up based on protocol requirements and sponsor specifications.
• Apply knowledge of informed consent processes to ensure that related source documentation is accurate, complete, and compliant.
• Utilize interactive web response systems (IWRS) and EDC tools as part of the documentation and data verification workflow.

Require Skills & Experience

• 1-3+ years of clinical research experience, preferably in a Clinical Research Coordinator, regulatory, or data-focused role.
• Hands-on experience with interventional clinical trials, ideally in a dermatology or similar therapeutic area.
• Strong understanding of source documentation practices and their role in clinical trial integrity.
• Solid knowledge of Good Clinical Practice (GCP) guidelines and FDA regulations related to clinical research.
• Familiarity with clinical trial workflows, including study start-up, conduct, and closeout activities.
• Experience using electronic data capture (EDC) systems and/or clinical trial management systems (CTMS).
• Demonstrated experience creating or managing source documents for clinical studies.
• Working knowledge of informed consent processes and associated documentation requirements.
• Experience with IWRS (Interactive Web Response Systems) as part of clinical trial operations.

Job Type & Location

This is a Contract position based out of Fountain Valley, CA.

Pay and Benefits

The pay range for this position is $28.00 - $30.00/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 onsite position in Fountain Valley,CA.

Application Deadline

This position is anticipated to close on May 29, 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.