Clinical Research Regulatory Admin Coordinator

Source Document Specialist Dermatology Clinical Trials

The Source Document Specialist plays a key role in supporting dermatology industry-initiated clinical trials by developing, standardizing, and maintaining accurate source documentation. This position works closely with Clinical Research Coordinators and the Regulatory Coordinator to ensure that all study documents are complete, compliant, and inspection-ready in alignment with GCP, FDA regulations, and study protocols. The role is ideal for someone with clinical research experience who enjoys detail-oriented work, quality control, and collaborating within a high-volume, fast-paced research environment.

Responsibilities

• Develop, create, and standardize source document templates based on study protocols and sponsor requirements.
• Review study protocols, schedules of events, and case report forms (CRFs) to ensure source documents capture all required data points.
• Maintain version control of source documents and implement updates when protocols are amended.
• Perform ongoing quality checks to ensure completeness, accuracy, and consistency between source data and electronic data capture (EDC) entries.
• Identify gaps, discrepancies, or missing data in source documentation and collaborate with Clinical Research Coordinators to resolve issues promptly.
• Support the Regulatory Coordinator by ensuring all source documentation is compliant, audit-ready, and inspection-ready at all times.
• Assist in building and organizing source documents during study start-up based on protocol requirements.
• Apply knowledge of informed consent processes to ensure appropriate documentation is captured and maintained.
• Utilize systems such as IWRS and EDC to support data capture and documentation workflows.
• Contribute to efficient clinical trial workflows by aligning source documentation practices with GCP and FDA regulations.
• Work independently to manage documentation tasks while communicating effectively with the broader research team.
• Demonstrate strong problem-solving skills when addressing documentation or data quality issues in a fast-paced research setting.

Essential Skills

• 13+ years of clinical research experience, preferably in a CRC, regulatory, or data-focused role.
• Hands-on experience with interventional clinical trials.
• Strong understanding of source documentation practices in clinical research.
• Knowledge of Good Clinical Practice (GCP) guidelines and FDA regulations.
• Familiarity with clinical trial workflows and study start-up processes.
• Experience using electronic data capture (EDC) systems and/or clinical trial management systems (CTMS).
• Experience creating or managing source documents for clinical studies.
• Understanding of informed consent documentation requirements.
• Experience working with IWRS and EDC platforms.
• Detail-oriented approach with strong organizational and quality control skills.
• Ability to work independently and manage responsibilities with minimal supervision.
• Ability to operate effectively in a fast-paced, high-volume clinical research environment.
• Resilience and comfort receiving direct feedback in a professional manner.
• Strong problem-solving skills and the ability to address documentation and data issues proactively.

Additional Skills & Qualifications

• Bilingual proficiency, which is beneficial for supporting diverse patient populations and documentation needs.
• Phlebotomy skills and phlebotomy certification are advantageous for supporting study procedures when needed.
• Ability to collaborate closely with Clinical Research Coordinators, Regulatory Coordinators, and other research staff.
• Comfort working in a combined private practice and clinical research setting with high sponsor engagement.

Work Environment

This is a fully onsite position in a busy dermatology private practice and clinical research site that has been conducting research for decades and now manages a high volume of sponsor-initiated studies. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., with a 12:00 p.m. to 1:00 p.m. lunch break. The site frequently receives catered lunches provided by sponsors. The facility offers a full parking lot with easy access. You will report to the Director of Operations and work directly with the Regulatory Coordinator, supporting a team of approximately 10 Clinical Research Coordinators and about 4 Regulatory or Research Assistants. The environment is fast-paced, sponsor-driven, and highly active, providing exposure to multiple concurrent dermatology clinical trials and modern research systems such as EDC and IWRS.

Job Type & Location

This is a Contract to Hire 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 Aug 4, 2026.