Clinical Research Associate

Job Title: Clinical Trial Documentation Specialist

Pay Rate: $45 to $48.33/HR

Duration: 16 months

Location: Irvine, CA (Hybrid - 2 days onsite (Monday & Tuesday) & 3 days remote)

Our Client is a Global medical device Manufacturer.

We are seeking a Clinical Trial Documentation Specialist to support
clinical trial documentation activities, with a primary focus on
Trial Master File (TMF) document review and quality. The role will conduct detailed
reviews of clinical trial documentation, investigate discrepancies, and identify opportunities to improve processes. The ideal candidate is a critical thinker with a strong sense of ownership, curiosity, and willingness to learn. Prior sponsor experience and knowledge of clinical/regulatory requirements are preferred


- Conduct detailed reviews of Trial Master File (TMF) documentation to ensure completeness, accuracy, and compliance with applicable requirements.
- Investigate documentation discrepancies, identify root causes, and support appropriate resolution.
- Identify process gaps and recommend improvements to enhance documentation quality and efficiency.
- Navigate and work within Veeva to review, manage, and track clinical trial documentation.
- Utilize Medidata Rave for clinical trial data and documentation-related activities.
- Perform document and data reviews using advanced Excel skills.
- Support Informed Consent Form (ICF) reviews as needed.
- Apply knowledge of regulatory requirements and clinical trial processes to documentation review activities.
- Collaborate with cross-functional team members to resolve issues and maintain high-quality trial documentation.
- Maintain a high level of organization, accuracy, and attention to detail across assigned activities.


Must Have Skills:


- Veeva
- Medidata Rave
- Advanced Excel
- TMF/document review
- Clinical/regulatory knowledge
- Strong attention to detail


Requirements:


- Approximately 1–2 years of relevant clinical research, clinical operations, regulatory, TMF, or pharmaceutical/biotech experience preferred.
- Hands-on experience navigating Veeva – Required.
- Experience with Medidata Rave – Required.
- Advanced Excel skills – Required.
- Understanding of clinical/regulatory requirements.
- Strong attention to detail and organizational skills.
- Strong critical-thinking and problem-solving abilities.
- Ability to investigate discrepancies and identify process improvements.
- Strong sense of ownership and accountability.
- Ability to work effectively in a team-oriented environment.
- Curious, adaptable, and eager to learn.


Preferred Qualifications


- Prior clinical trial sponsor experience.
- Experience with TMF document review.
- Experience reviewing Informed Consent Forms (ICFs).
- Clinical research certification such as CRA, CRC, or related certification.
- Knowledge of clinical trial documentation and regulatory requirements.