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Trial Master File Jobs in Remote, OR (NOW HIRING)

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Trial Master File information

What are the key skills and qualifications needed to thrive in the Trial Master File position, and why are they important?

To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.

What is a Trial Master File job?

A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.

What are the typical responsibilities and daily tasks of a Trial Master File (TMF) Specialist?

As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.

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Trial Master File jobs near you
Infographic showing various Trial Master File job openings in Remote, OR as of July 2026, with employment types broken down into 78% Full Time, 18% Part Time, 1% Temporary, and 3% Contract. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution.

Senior Clinical Research Associate

Nexpro Technologies Inc

OR • Remote

$90K - $120K/yr

Full-time

Medical

Posted 16 days ago

Job description

We are seeking a detail-oriented and motivated Clinical Research Associate (CRA) to oversee and monitor clinical trials while ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. The ideal candidate will have experience in site monitoring, clinical trial management, and maintaining high-quality clinical data.

Key Responsibilities

  • Monitor clinical trial sites to ensure compliance with study protocols, ICH-GCP, SOPs, and applicable regulatory guidelines.
  • Conduct Site Initiation Visits (SIV), Site Monitoring Visits (SMV), and Close-Out Visits (COV).
  • Verify source data and ensure data accuracy, integrity, and completeness.
  • Maintain Trial Master File (TMF) and essential study documentation.
  • Build and maintain strong relationships with investigators and site staff.
  • Identify, document, and resolve protocol deviations and study-related issues.
  • Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
  • Review informed consent documentation and ensure participant safety.
  • Prepare monitoring visit reports and follow-up letters.
  • Coordinate with Clinical Operations, Data Management, Biostatistics, Medical Writing, and Regulatory teams.
  • Support study start-up, patient recruitment, and site management activities.
  • Ensure studies are completed within timelines and quality standards.

Required Qualifications

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related field.
  • 2–6 years of experience as a Clinical Research Associate in clinical trials.
  • Strong knowledge of ICH-GCP, FDA, EMA, and local regulatory requirements.
  • Experience with EDC systems, CTMS, and eTMF platforms.
  • Excellent communication, documentation, and organizational skills.
  • Willingness to travel for site monitoring visits.

Preferred Skills

  • Clinical site monitoring experience across multiple therapeutic areas.
  • Knowledge of protocol review, source document verification (SDV), and risk-based monitoring.
  • Strong analytical and problem-solving abilities.
  • Ability to manage multiple studies simultaneously and work independently.

Benefits

  • Competitive salary and performance incentives.
  • Health insurance and employee wellness programs.
  • Learning and career development opportunities.
  • Collaborative and supportive work environment.

Company Description

NexPro Technologies offers robust, responsive and value-driven IT consulting and placement services.