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Trial Master File Associate Jobs (NOW HIRING)

Clinical Trial Associate

Manhattan, NY

$36.75 - $50.25/hr

The Clinical Trial Associate (CTA) supports clinical study teams in the execution and oversight of ... Maintain accurate, complete, and inspection-ready Trial Master Files (electronic or paper)

Clinical Trial Associate

Manhattan, NY ยท On-site

$36.75 - $50.25/hr

The Clinical Trial Associate (CTA) supports clinical study teams in the execution and oversight of ... Maintain accurate, complete, and inspection-ready Trial Master Files (electronic or paper)

TMF Manager

Auburn, ME ยท On-site

$36 - $49.25/hr

The Trial Master File (TMF) is a collection of documentation that allows the conduct of a clinical ... TMF Associates and Administrators. Requirements Bachelor's degree; A minimum of 5 years of ...

Clinical Trial Assistant

New York, NY ยท On-site

$75K - $85K/yr

This means maintaining our Trial Master File, coordinating with CROs and sites, managing ... Serve as the primary point of contact between Pathos and CRO Clinical Research Associates for day ...

Reporting to a Sr. Clinical Project Manager of Clinical Operations, the Associate Clinical Trial ... The aCTM will also manage the creation, organization, maintenance, and quality of Trial Master File ...

Clinical Trial Associate

$34.25 - $46.75/hr

The Clinical Trial Associate ("CTA") is a highly skilled specialist contributing to the development ... Maintain the Trial Master File for all clinical projects * Perform periodic reviews and QC of the ...

Reporting to a Sr. Clinical Project Manager of Clinical Operations, the Associate Clinical Trial ... The aCTM will also manage the creation, organization, maintenance, and quality of Trial Master File ...

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Trial Master File Associate information

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 are the key skills and qualifications needed to thrive as a Trial Master File Associate, and why are they important?

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 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 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.
More about Trial Master File Associate jobs
What cities are hiring for Trial Master File Associate jobs? Cities with the most Trial Master File Associate job openings:
What are the most commonly searched types of Trial Master File jobs? The most popular types of Trial Master File jobs are:
What states have the most Trial Master File Associate jobs? States with the most job openings for Trial Master File Associate jobs include:
Infographic showing various Trial Master File Associate job openings in the United States as of May 2026, with employment types broken down into 66% Full Time, and 34% Part Time. Highlights an 75% Physical, 5% Hybrid, and 20% Remote job distribution.
Clinical Trial Assistant

Clinical Trial Assistant

Rigel Pharmaceuticals Inc.

South San Francisco, CA โ€ข On-site

$78K - $95K/yr

Full-time

Posted 26 days ago


Job description

POSITION SUMMARY:
This opportunity will support the Clinical Operations team in a fast paced, busy hematology/oncology pharmaceutical development department. As a Clinical Trial Assistant (CTA), you will assist the clinical research teams in clinical trial conduct, oversight, and logistics by providing administration and project tracking support.
Salary Range: Premium (NY/CA) $78,000 to $95,000
ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Provide administrative support to the Clinical Operations Department.
  • Assist Clinical Operations in minute generation and finalization of study related meetings. .
  • Support the Clinical Operations teams with archived, ongoing, and future clinical conduct of studies.
  • Be familiar with ICH, GCP, appropriate regulations, Rigel SOPs and internal systems.
  • Assist internal and external project teams with documentation and guidelines as appropriate.
  • Maintains and manages the study trial master files using Veeva Vault and other platforms.
  • Organize study documentation, including archiving, reviewing, and standardizing local study files for department consistency.
  • Accurately uploading and filing study documents to the Veeva Vault electronic Trial Master File.
  • Ensures study documents filed into the Veeva Vault electronic Trial Master File comply with filing guidelines and acceptability criteria. This includes, but is not limited to, reviewing documents for accuracy, quality and legibility, pagination, layout orientation, filing location, and compliance with GCP guidelines.
  • Provides additional support in quality reviews of study the trial master file plans and indexes.
  • Route and manage correspondence for the clinical trial teams.
  • Provides administrative support with department project planning, execution, and follow up.
  • Assist with team member tracking and distribution of study related information.
  • Tracking of screening, enrollment, and subject status reports from CRO and sites.

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Bachelor's degree in science related field required. 1-2 years' experience in clinical research type role preferred.

WORKING CONDITIONS:
  • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
  • WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.