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Trial Master File Associate Jobs in California (NOW HIRING)

StartX

Clinical Trial Associate

Redwood City, CA · On-site

$41 - $56/hr

The Clinical Trial Associate (CTA) supports CRAs, and study teams across Karius clinical studies by ... Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs ...

Karius

Clinical Trial Associate

Redwood City, CA · On-site +1

$41 - $56/hr

The Clinical Trial Associate (CTA) supports CRAs, and study teams across Karius clinical studies by ... Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs ...

Karius, Inc.

Clinical Trial Associate

Redwood City, CA · On-site

$41 - $56/hr

Position Summary The Clinical Trial Associate (CTA) supports CRAs, and study teams across Karius ... Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs ...

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Trial Master File Associate information

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What are the most commonly searched types of Trial Master File jobs in California?

The most popular types of Trial Master File jobs in California are:

What are popular job titles related to Trial Master File Associate jobs in California?

For Trial Master File Associate jobs in California, the most frequently searched job titles are:

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The top searched job categories for Trial Master File Associate jobs in California are:

What cities in California are hiring for Trial Master File Associate jobs?

Cities in California with the most Trial Master File Associate job openings:

Trial Master File Associate jobs near you

Trial Master File (TMF) Associate

Menlo Park, CA • On-site, Remote

Oruka Therapeutics
See more jobs at Oruka Therapeuticsexternal

$104K - $125K/yr

Full-time

Posted yesterday

New

Job description

Job Title:     Trial Master File (TMF) Associate

Location:     Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.

Job Summary

We are seeking a highly organized and detail-oriented Trial Master File (TMF) Associate to support the management, quality, and inspection readiness of clinical trial documentation throughout the clinical study lifecycle. The TMF Associate serves as a key partner to Clinical Operations, CROs, vendors, and study teams, ensuring TMF records are complete, accurate, contemporaneous, and maintained in accordance with ICH-GCP guidelines, regulatory requirements, and company procedures. This role contributes to TMF oversight activities, quality reviews, reconciliation efforts, health metric reporting, and continuous process improvement initiatives to support an inspection-ready TMF environment.

Responsibilities:

  • Maintain assigned study TMFs and ensure documents are filed accurately, contemporaneously, and according to TMF standards and company procedures.
  • Perform routine quality control reviews to identify missing, incomplete, duplicate, or misfiled documents and drive timely resolution with study teams and functional areas.
  • Monitor TMF health, completeness, and timeliness metrics; proactively communicate risks, trends, and outstanding issues to stakeholders.
  • Partner with Clinical Operations, CROs, vendors, and cross-functional teams to ensure consistent document flow and adherence to TMF filing expectations.
  • Support vendor and CRO reconciliation activities and assist with management of TMF transfer processes to ensure documentation completeness across all sources.
  • Assist in preparing for audits and regulatory inspections by ensuring TMF documentation is complete, accessible, and inspection-ready.
  • Track, reconcile, and help resolve TMF queries, issues, and corrective actions in collaboration with study teams and vendors.
  • Support TMF plans, filing guidance, work instructions, SOPs, and other TMF-related documentation as needed.
  • Assist with user support, training, and adoption of eTMF processes and systems.
  • Contribute to TMF process improvements and quality initiatives that enhance compliance, efficiency, and inspection readiness.
  • Maintain compliance with company SOPs, ICH-GCP guidelines, and applicable regulatory requirements.

Requirements:

  • Bachelor's degree in Life Sciences, Health Sciences, or related fields or equivalent.
  • 2-4+ years of experience in TMF management, clinical document management, clinical operations, or clinical research within biotechnology, pharmaceutical, or CRO environments.
  • Working knowledge of the CDISC TMF Standard Model, ICH-GCP R(3) guidelines, 21 CFR Part 11, and applicable FDA and global regulatory requirements.
  • Experience maintaining electronic Trial Master Files (eTMF) in regulated clinical trial environments.
  • Hands-on experience with Veeva Vault eTMF and/or Trial Interactive platforms required.
  • Experience with TMF quality control, completeness reviews, reconciliation activities, and inspection readiness support.
  • Ability to analyze TMF health metrics and identify risks, trends, and gaps requiring follow-up.
  • Demonstrated commitment to quality, compliance, and continuous improvement.

Preferred Requirements:

  • Experience supporting FDA BIMO regulatory inspections.
  • Experience supporting global clinical studies across multiple phases and working directly with CROs and external vendors.
  • Familiarity with CTMS platforms and TMF-related inspection preparation activities.
  • Experience supporting SOP development, TMF training, or process improvement initiatives.

Compensation:

An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. The anticipated salary range for Associate level is $104,000 - $125,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states. 

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

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