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Freelance Trial Master File Jobs in Kansas (NOW HIRING)

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Sets up and maintains Trial Master File (eTMF) * Ensures alignment of budget with protocol needs * Responsible for executing protocol within the budget * Responsible for creating and maintaining ADI ...

IQVIA

Clinical Research Associate

Overland Park, KS

$71K - $189K/yr

Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF). * Prepare comprehensive monitoring reports, follow-up ...

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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Freelance Trial Master File information

What are some common challenges faced by freelance trial master file professionals, and how can they be addressed?

Freelance TMF professionals often encounter challenges such as maintaining document consistency across multiple studies and sponsors, adapting to various electronic TMF (eTMF) systems, and ensuring compliance with evolving regulatory requirements. To address these challenges, it's essential to develop strong organizational skills, stay current with industry regulations like ICH-GCP, and become proficient in commonly used eTMF platforms. Regular communication with sponsors and clinical teams also helps resolve discrepancies quickly and ensures timely document submission.

What is a freelance trial master file?

A Freelance Trial Master File (TMF) specialist is an independent professional who manages and maintains the Trial Master File for clinical trials. The TMF is an organized collection of essential documents that demonstrate the compliance of a clinical trial with regulatory requirements and Good Clinical Practice (GCP) guidelines. Freelance TMF specialists typically work on a contract basis with pharmaceutical companies, contract research organizations (CROs), or clinical trial sponsors to ensure that all trial documentation is complete, accurate, and audit-ready.

What are the key skills and qualifications needed to thrive as a freelance trial master file specialist?

To thrive as a Freelance Trial Master File Specialist, you need a strong understanding of clinical trial documentation, regulatory requirements (such as ICH-GCP), and experience in managing TMF processes. Familiarity with electronic TMF (eTMF) systems, document management tools, and possibly certifications like DIA's TMF Management certificate are typically required. Excellent organizational skills, attention to detail, and effective communication are crucial soft skills for ensuring document accuracy and stakeholder collaboration. These skills are vital for maintaining compliant, audit-ready TMFs that support successful clinical trial execution and regulatory submissions.

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 Freelance Trial Master File jobs in Kansas?

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

What job categories do people searching Freelance Trial Master File jobs in Kansas look for?

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

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

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

Freelance Trial Master File jobs near you

Senior Clinical Research Associate, Sponsor Aligned, Oncology

IQVIA Argentina

Overland Park, KS • On-site

$71.90 - $189/hr

Other

Posted 7 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! 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
  • Conduct site monitoring visits – selection, initiation, monitoring, and close‑out – 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 start‑up phases.
  • Ensure all site documents are filed in the Trial Master File and Investigator’s Site File per GCP/ICH and local regulations.
  • Generate visit reports, follow‑up letters, and other necessary documentation.
  • Mentor clinical staff through co‑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 on‑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 problem‑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. 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.

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 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.

Compensation

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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