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Trial Master File Associate Jobs in Kansas (NOW HIRING)

IQVIA

Clinical Research Associate

Overland Park, KS · On-site

$71K - $189K/yr

Clinical Research Associate II & Senior Clinical Research Associate (CRA II/Sr. CRA) Multiple ... Trial Master File (TMF) and Investigator Site File (ISF). * Prepare comprehensive monitoring ...

IQVIA

Clinical Research Associate

Overland Park, KS · On-site

$87K - $182K/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 ...

IQVIA

Clinical Research Associate

Overland Park, KS · 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 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 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 job categories do people searching Trial Master File Associate jobs in Kansas look for?

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

Trial Master File Associate jobs near you
Infographic showing various Trial Master File Associate job openings in Kansas as of August 2026, with employment types broken down into 73% Full Time, and 27% Contract. Highlights an 74% In-person, and 26% Remote job distribution.

Senior Clinical Research Associate, Sponsor Aligned, Oncology

Overland Park, KS • On-site

IQVIA
Health Care and Social Assistance • 10K+ employees
Learn more about IQVIAexternal

$71K - $189K/yr

Full-time

Re-posted 17 days ago

IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 53 frontline employees who took The Breakroom Quiz

Job description

Job Overview:
Join our dynamic team as a Clinical Research Associate! You'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 patients' lives.

Key Responsibilities
Site Monitoring Visits: Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines.
Subject Recruitment: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
Training & Communication: Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues.
Quality Assurance: Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
Study Progress Management: Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution. Support start-up phases as required.
Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP/ICH and local regulations.
Reporting: Generate visit reports, follow-up letters, and other necessary documentation.
Mentorship: Mentor clinical staff through co-monitoring and training visits.
Collaboration: Work closely with study team members to support project execution.

Qualifications
Education: BS degree required; a degree in a scientific discipline or healthcare is preferred.
Experience: 3+ years of on site oncology monitoring experience strongly preferred. 1.5+ years of oncology monitoring experience can be 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 problem-solving abilities.
Strong time management skills.
Ability to build and maintain effective working relationships.

Why Join Us?
Be part of a team that's pushing the boundaries of cancer research. You'll have the opportunity to work on cutting-edge Phase 1 oncology trials, collaborate with top professionals in the field, and contribute to life-changing advancements in cancer treatment. If you're passionate about making a difference and have the expertise we're looking for, we'd love to hear from you!

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. Learn more athttps://jobs.iqvia.com

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. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero 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. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-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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About IQVIA

Sourced by ZipRecruiter

At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Durham, NC, US

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