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Trial Master File Associate Jobs in Kansas (NOW HIRING)

Clinical Research Associate

Overland Park, KS ยท On-site

$71K - $189K/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 ...

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 ...

Clinical Research Associate

Overland Park, KS ยท On-site

$71K - $189K/yr

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

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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?

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 Kansas?

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

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

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

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

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

Infographic showing various Trial Master File Associate job openings in Kansas as of August 2026, with employment types broken down into 71% Full Time, and 29% Contract. Highlights an 74% In-person, and 26% Remote job distribution.

Senior Clinical Research Associate, Sponsor Aligned, Oncology

IQVIA Argentina

Overland Park, KS โ€ข On-site

$71.90 - $189/hr

Other

Posted 6 days ago


Job description

Senior Clinical Research Associate, Sponsor Aligned, Oncology

Overland Park, United States of America | Full time | Field-based | R1541483

Job Overview

Join our dynamic team as a Clinical Research Associate! Youโ€™ll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements. Be at the forefront of groundbreaking cancer research and make a real impact on patientsโ€™ lives.

Key Responsibilities
  • Conduct site monitoring visits โ€“ selection, initiation, monitoring, and closeโ€‘out โ€“ in line with GCP and ICH guidelines.
  • Collaborate with sites to develop and track recruitment plans to meet project needs.
  • Provide protocol and study training, maintain regular communication to manage expectations and address issues.
  • Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
  • Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution; support startโ€‘up phases.
  • Ensure all site documents are filed in the Trial Master File and Investigatorโ€™s Site File per GCP/ICH and local regulations.
  • Generate visit reports, followโ€‘up letters, and other necessary documentation.
  • Mentor clinical staff through coโ€‘monitoring and training visits.
  • Work closely with study team members to support project execution.
Qualifications
  • BS degree required; a degree in a scientific discipline or healthcare is preferred.
  • 3+ years of onโ€‘site oncology monitoring experience strongly preferred; 1.5+ years considered. Phase 1 oncology experience is required.
Skills
  • Proficient in GCP and ICH guidelines.
  • Strong therapeutic and protocol knowledge in Phase 1 oncology trials.
  • Excellent computer skills, including Microsoft Office and mobile devices.
  • Effective communication, organizational, and problemโ€‘solving abilities.
  • Strong time management skills.
  • Ability to build and maintain effective working relationships.
Why Join Us

Be part of a team that is pushing the boundaries of cancer research. Youโ€™ll have the opportunity to work on cuttingโ€‘edge Phase 1 oncology trials, collaborate with top professionals in the field, and contribute to lifeโ€‘changing advancements in cancer treatment.

About IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Equal Opportunity Employer

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

Integrity Commitment

IQVIA is committed to integrity in our hiring process and maintains a zeroโ€‘tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.

Compensation

The potential base pay range for this role, when annualized, is $71,900.00 โ€“ $189,000.00. The actual base pay offered may vary based on a number of factors including jobโ€‘related qualifications such as knowledge, skills, education, and experience; location; and / or schedule (full or partโ€‘time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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