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Trial Master File Associate Jobs in Houston, TX (NOW HIRING)

Senior Clinical Research Associate

Houston, TX ยท On-site

$120K - $135K/yr

Associate Director, Team Lead Site Operations Location :FullyRemote Salary Range: $120,000 to $135 ... Maintainaccurateandtimelymonitoring documentation, including trip reports and trial master file ...

Senior Clinical Research Associate

Houston, TX ยท On-site

$120K - $135K/yr

Associate Director, Team Lead Site Operations Location : Fully Remote Salary Range: $120,000 to ... Maintain accurate and timely monitoring documentation, including trip reports and trial master file ...

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

CRA 2, Oncology, IQVIA

Houston, TX ยท On-site

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

CRA 1, IQVIA Biotech

Houston, TX ยท On-site

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

Villarreal & Associates, insurance staff counsel for State Farm Insurance Companies, is seeking ... File ownership * Effective written and oral communication skills Technology/software experience ...

Villarreal & Associates, insurance staff counsel for State Farm Insurance Companies, is seeking ... File ownership * Effective written and oral communication skills Technology/software experience ...

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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.
What are the most commonly searched types of Trial Master File jobs in Houston, TX? The most popular types of Trial Master File jobs in Houston, TX are:
What are popular job titles related to Trial Master File Associate jobs in Houston, TX? For Trial Master File Associate jobs in Houston, TX, the most frequently searched job titles are:
What cities near Houston, TX are hiring for Trial Master File Associate jobs? Cities near Houston, TX with the most Trial Master File Associate job openings:
Infographic showing various Trial Master File Associate job openings in Houston, TX as of July 2026, with employment types broken down into 83% Full Time, and 17% Contract. Highlights an 100% In-person job distribution.

Senior Clinical Research Associate

Immatics NV

Houston, TX โ€ข On-site

$120K - $135K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 19 days ago


Job description

JoinImmaticsandshape thefuture ofcancerimmunotherapy; one patient at atime!

Immaticsis committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting ofPRAME, a target expressed in more than 50 cancers. Ourcutting-edgescience and robust clinical pipeline form the broadestPRAMEfranchise with the mostPRAMEindications and modalities, spanning TCR T-cell therapies and TCRbispecifics.

Why Join Us?

  • Innovative Environment:Helptopioneeradvancementsin cancer immunotherapy.

  • Collaborative Culture:Be part ofa diverse team dedicated to your professionalgrowth.

  • Global Impact:Contributeto therapies thatmakealasting impactonpatientsglobally.

Role Overview:

We are seeking a Senior Clinical Research Associate (CRA) to support our Clinical Operations team. The Senior CRA willbe responsible foroverseeing clinical trial site management and monitoring activities to ensure compliance with ICH-GCP, regulatory requirements, and company SOPs. In this role, you will partner closely with clinical sites and cross-functional teams to support high-quality study execution, patient recruitment, and operational excellence across clinical trials.

Reports to:Associate Director, Team Lead Site Operations

Location:FullyRemote

Salary Range:$120,000 to $135,000

Basic Qualifications:

  • Bachelor's degree in life sciences, nursing, or a related field

  • 4+ years of on-site monitoring experience within the pharmaceutical or biotechnology industry, including all clinical monitoring visit types

  • Strong knowledge of ICH-GCP, FDA, EMA, and applicable clinical trial regulations

  • Demonstrated experience managing clinical trial sites,monitoringactivities, and clinical trial documentation

  • Proficiencywith clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office)

PreferredQualifications:

  • Experience in oncology clinical trials or related therapeutic areas

  • Advanced presentation, organizational, and stakeholder management skills

  • Experience mentoring or training junior CRAs and supporting cross-functional clinical operations activities

  • Demonstrated ability to drive quality, efficiency, and continuous improvement initiatives in clinical operations

  • Strong understanding of clinical trial recruitment strategies, data capture, and site engagement best practices

  • Experience contributing to global harmonization, process optimization, or operational innovation initiatives

In thisrole youwill:

  • Conduct all clinical monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits

  • Support site feasibility, siteselection, and ongoing site management activities throughout the clinical trial lifecycle

  • Review clinical trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives

  • Maintainaccurateandtimelymonitoring documentation, including trip reports and trial master file records

  • Collaborate with vendors, clinical sites, and cross-functional teams to support study execution and operational compliance

  • Participate in investigator meetings, clinical trial documentation development, and study team meetings

  • Mentor junior CRA team members and contribute to continuous improvement of clinical operations processes and procedures

Travel required:Willingness to travel up to 75%. Valid Driver's License preferable.

Qualified candidates willparticipatein a structured interview process, which includes:

  • An initialrecruiter phone screen (conducted via video)

  • A recruiter-facilitated introduction and interview with the hiring leader and key stakeholders (via video)

  • A final-stage interview, which may include an in-person meeting at our U.S. Headquarters in Houston, TX

What do we offer?

AtImmatics, we believe in investing in our team's health,safetyand well-being.Here'swhat you can expectif youjoinImmatics

Comprehensive Benefits:

  • Competitive rates forHealth, Dental, and Vision Insurance

  • 4 weeks ofvacation,granted up front each year and prorated for firstand lastyear ofemployment.

  • 12 company paid holidays

  • 7daysof sick time

  • 100%employer-paidlifeinsuranceup toat 1x annual salary, up to one hundred thousand dollars

  • 100%employer-paidshort- andlong-Termdisabilitycoverage

  • 401(k) withimmediateeligibilityandcompany match. The company will match100% of your contributions upto3% of yourbase salaryfor the first two yearsof employment, 4% foryears 2-3 of employment, and up to5%of your salaryfrom the fourth year onward of continued employment.

  • Partiallypaidparentalleavefor eligible employees.

  • Additionalvoluntary employee-paidbenefits and services,includingaccident,hospitalindemnity, andcriticalillnessinsurance, as well as identitytheftprotection andpetinsurance.

Equal Employment Opportunity

We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard torace, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexualorientation, gender identity or expression, national origin, ancestry, age, marital status, disability, geneticinformation, veteran status, or any other status protected by applicable law.

Reasonable Accommodations

We are committed to providing reasonable accommodations to individuals with disabilities and to applicants withsincerely heldreligious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us atRecruitingUS@immatics.com.

Work Authorization

Applicants mustbe authorized towork in the United States without the need for current or future sponsorship. Visa sponsorships may beavailablefor certain roles.

Pre-Employment Requirements

Employment is contingent upon successful completion of a background check, referencechecksand pre-employment drug screening, wherepermittedby applicable law. For certain roles,additionalscreenings such as a credit check or motor vehicle record review may berequired, where job-related and consistent with business necessity.