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Trial Master File Associate Jobs in Chicago, IL (NOW HIRING)

IQVIA Argentina

CRA 2, Oncology, IQVIA

Chicago, IL · On-site

$87.20 - $145.30/hr

Ensure copies or originals of required site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) complies with GCP and local regulatory ...

IQVIA

CRA 2, Oncology, IQVIA

Chicago, IL

$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 ...

IQVIA

CRA 2, Oncology, IQVIA

Chicago, IL

$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 ...

IQVIA

CRA 1, IQVIA Biotech

Rosemont, IL · 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 ...

IQVIA

CRA 1, IQVIA Biotech

Rosemont, IL · 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 ...

Tempus

Director, (GCP) Quality Assurance

Chicago, IL · On-site

$160 - $200/hr

Conduct audits, including Internal, Investigator Site and Trial Master File.* Host and support company regulatory GCP inspections.* Oversee the clinical quality system document control process ...

Tempus

Director, (GCP) Quality Assurance

Chicago, IL · On-site +1

Conduct audits, including Internal, Investigator Site and Trial Master File. * Host and support company regulatory GCP inspections. * Oversee the clinical quality system document control process ...

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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 Chicago, IL?

The most popular types of Trial Master File jobs in Chicago, IL are:

What are popular job titles related to Trial Master File Associate jobs in Chicago, IL?

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

What job categories do people searching Trial Master File Associate jobs in Chicago, IL look for?

The top searched job categories for Trial Master File Associate jobs in Chicago, IL are:

What cities near Chicago, IL are hiring for Trial Master File Associate jobs?

Cities near Chicago, IL 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 Chicago, IL as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

CRA 2, Oncology, IQVIA

IQVIA Argentina

Chicago, IL • On-site

$87.20 - $145.30/hr

Other

Posted 9 days ago

Job description

Job Overview

Durham, United States of America | Full time | Field-based | R1537618

IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:

This role focuses on in‑site monitoring of oncology clinical trials, ensuring adherence to Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and contractual scope of work.

Essential Functions
  • Perform site monitoring visits (selection, initiation, monitoring and close‑out) per contractual scope and regulatory requirements.
  • Work with sites to adapt, drive, and track subject recruitment plans to meet project needs.
  • Administer protocol and related study training to assigned sites and maintain regular communication with sites to manage project expectations and issues.
  • Evaluate the quality and integrity of study site practices, ensuring proper conduct of the protocol and adherence to applicable regulations; escalates quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution; may support the start‑up phase.
  • Ensure copies or originals of required site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) complies with GCP and local regulatory requirements.
  • Create and maintain documentation of site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow‑up letters, and other required study documentation.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • If applicable, may be accountable for supporting the development of project subject recruitment plan on a per‑site basis.
  • If applicable, may be accountable for site financial management per the clinical trial agreement and retrieve invoices according to local requirements.
Qualifications
  • Education: Bachelor’s Degree in a scientific discipline or health care preferred.
  • Experience: 1.5 to 2 years of relevant CRA experience, including on‑site monitoring in oncology.
Compensation

The potential base pay range for this role, when annualized, is $87,200.00 – $145,300.00. Actual compensation may vary based on qualifications, location, schedule, and other factors. Incentive plans, bonuses, and additional compensation may be offered along with a range of health and welfare benefits.

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. EEO Statement

Integrity Policy

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements, misrepresentations, or material omissions will result in immediate disqualification or, if discovered later, termination, in accordance with applicable law.

Location

Durham, United States of America

Employment Type

Field‑based, Full time

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