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

IQVIA

CRA 1, IQVIA Biotech

Chicago, IL

$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

Chicago, IL

$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

Sr. Manager, Quality Assurance

Chicago, IL · On-site

Directly conduct audits, including Internal, Investigator Site, and Trial Master File (TMF) audits. * Provide vital operational support during company regulatory GCP inspections and client audits.

Tempus

Sr. Manager, Quality Assurance

Chicago, IL

Directly conduct audits, including Internal, Investigator Site, and Trial Master File (TMF) audits. * Provide vital operational support during company regulatory GCP inspections and client audits.

Segal McCambridge

Associate Attorney

Chicago, IL · Hybrid

$100K - $155K/yr

Draft pleadings, motions, written discovery, and other litigation-related filings * Take and defend ... Gain hands-on experience in all phases of litigation through trial and resolution This role is ...

Segal McCambridge

Associate Attorney

Chicago, IL · On-site +1

$100K - $155K/yr

Draft pleadings, motions, written discovery, and other litigation-related filings * Take and defend ... Gain hands-on experience in all phases of litigation through trial and resolution This role is ...

Segal McCambridge

Associate Attorney (Remote)

Chicago, IL · Remote

$100K - $155K/yr

Draft pleadings, motions, written discovery, and other litigation-related filings * Take and defend ... Gain hands-on experience in all phases of litigation through trial and resolution This role is ...

Crafted Staff

0162 - Associate Attorney

Chicago, IL · On-site

$100K - $120K/yr

Manage a caseload of bodily injury litigation files from suit through trial * Draft pleadings, motions, discovery requests/responses, and legal correspondence * Attend court hearings, depositions ...

Crafted Staff

0162 - Associate Attorney

Chicago, IL · On-site

$100K - $120K/yr

Manage a caseload of bodily injury litigation files from suit through trial * Draft pleadings, motions, discovery requests/responses, and legal correspondence * Attend court hearings, depositions ...

SS&C

Associate Manager, Fund Accountant

Chicago, IL

$80K - $125K/yr

Review the daily work prepared by their associates including corporate action processing, pricing downloads, security master file setup, and other data * Proficient with the various software programs ...

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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 popular job titles related to Trial Master File Associate jobs in Wheaton, IL? For Trial Master File Associate jobs in Wheaton, IL, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Wheaton, IL look for? The top searched job categories for Trial Master File Associate jobs in Wheaton, IL are:
What cities near Wheaton, IL are hiring for Trial Master File Associate jobs? Cities near Wheaton, IL with the most Trial Master File Associate job openings:
Trial Master File Associate jobs near you
CRA 1, IQVIA Biotech

CRA 1, IQVIA Biotech

IQVIA

Chicago, IL

$71K - $145K/yr

Full-time

Re-posted 2 days ago

IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 53 frontline employees who took The Breakroom Quiz

55th of 210 rated it services

Job description

IQVIA Biotech is now hiring for CRA 1 with a minimum of 6 months of on-site monitoring. Must have experience monitoring in oncology solid tumor.

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Overview

The Clinical Research Associate I (CRA I) plays a key role in supporting the successful conduct of clinical research studies by performing site monitoring and site management activities. In this position, you will ensure that assigned study sites conduct trials in compliance with the protocol, applicable regulations, Good Clinical Practice (GCP), and ICH guidelines. This role is essential in protecting patient safety, ensuring highquality clinical data, and maintaining study integrity.

Key Responsibilities

As a CRA I, you will conduct various types of monitoring visits-including site selection, initiation, routine monitoring, and closeout visits-to evaluate the quality and integrity of site practices. You will verify that study activities are performed according to regulatory requirements and sponsor expectations, escalating quality concerns as necessary. During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the Investigator Site File (ISF).

A central part of this role involves building and maintaining strong communication with investigative sites. You will provide protocol training, set expectations, address sitelevel challenges, and support recruitment planning to help sites meet enrollment targets. You will also collaborate closely with internal project teams to ensure cohesive study execution and may contribute to site-level financial processes or startup activities based on study needs.

Accurate and timely documentation is critical. The CRA I prepare detailed monitoring visit reports, followup letters, and all required study documentation to ensure audit readiness and transparent oversight. The ability to manage multiple tasks, prioritize effectively, and work independently while maintaining productive team relationships is essential for success.

Qualifications

  • Bachelor's degree required; a scientific or healthcare discipline is preferred.
  • 6 months -2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
  • Basic knowledge of clinical research regulations (GCP/ICH).
  • Ability to travel as required by the project.

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 - $145,300.00. 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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