Related Document Processing experience with Associate s degree 2+ yrs. with Bachelor's degree Quality control experience preferred Qualifications Trial Master File, Documentation Additional ...
Related Document Processing experience with Associate s degree 2+ yrs. with Bachelor's degree Quality control experience preferred Qualifications Trial Master File, Documentation Additional ...
Clinical Trial Associate
Manhattan, NY · On-site
$36.75 - $50.25/hr
The Clinical Trial Associate (CTA) supports clinical study teams in the execution and oversight of ... Maintain accurate, complete, and inspection-ready Trial Master Files (electronic or paper)
Clinical Trial Associate
Manhattan, NY · On-site
$36.75 - $50.25/hr
The Clinical Trial Associate (CTA) supports clinical study teams in the execution and oversight of ... Maintain accurate, complete, and inspection-ready Trial Master Files (electronic or paper)
Clinical Trial Assistant
Raleigh, NC · On-site
... Associates (CRAs), and cross-functional project teams to ensure clinical studies are organized ... Establish, organize, and maintain the electronic Trial Master File (eTMF), ensuring inspection ...
Clinical Trial Assistant
Raleigh, NC · On-site
... Associates (CRAs), and cross-functional project teams to ensure clinical studies are organized ... Establish, organize, and maintain the electronic Trial Master File (eTMF), ensuring inspection ...
Senior Clinical Trial Associate
San Francisco, CA · On-site
$100K - $115K/yr
About the Role >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting ... Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study ...
Senior Clinical Trial Associate
San Francisco, CA · On-site
$100K - $115K/yr
About the Role >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting ... Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study ...
Senior Clinical Trial Associate
Boston, MA · On-site
$110K - $115K/yr
About the Role >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting ... Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study ...
Senior Clinical Trial Associate
Boston, MA · On-site
$110K - $115K/yr
About the Role >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting ... Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study ...
Clinical Records Associate - II Location: Foster City, CA Duration: 12 Months * Must meet all ... Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Assist in ...
Clinical Records Associate - II Location: Foster City, CA Duration: 12 Months * Must meet all ... Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Assist in ...
Clinical Trial Associate - Consultant at Clark Davis Associates Somerset County, NJ
Franklin Township, NJ · On-site
$70 - $100/hr
Clinical Trial Associate - Consultant job at Clark Davis Associates, Somerset County, NJ Clinical ... Perform regular reconciliations of the Trial Master File (TMF). * Ensure timely receipt of required ...
New
Clinical Trial Associate - Consultant at Clark Davis Associates Somerset County, NJ
Franklin Township, NJ · On-site
$70 - $100/hr
Clinical Trial Associate - Consultant job at Clark Davis Associates, Somerset County, NJ Clinical ... Perform regular reconciliations of the Trial Master File (TMF). * Ensure timely receipt of required ...
New
Familiarity with the clinical development process, understanding of trial master file. Qualifications Minimum Education Requirements: Associate's Degree required; Bachelor's Degree preferred. Minimum ...
Familiarity with the clinical development process, understanding of trial master file. Qualifications Minimum Education Requirements: Associate's Degree required; Bachelor's Degree preferred. Minimum ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Attovia Therapeutics, Inc., is seeking a Clinical Trials Associate (CTA) to join our Clinical ... Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Attovia Therapeutics, Inc., is seeking a Clinical Trials Associate (CTA) to join our Clinical ... Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master ...
Sr. Clinical Trial Associate (Hybrid - Acton, MA)
Acton, MA · On-site
$37 - $50.25/hr
Job Summary The Clinical Trial Associate (CTA) is a core member of the Clinical Affairs team and is ... Trial Master File (TMF) & Documentation Own the ongoing oversite, maintenance, quality, and ...
Sr. Clinical Trial Associate (Hybrid - Acton, MA)
Acton, MA · On-site
$37 - $50.25/hr
Job Summary The Clinical Trial Associate (CTA) is a core member of the Clinical Affairs team and is ... Trial Master File (TMF) & Documentation Own the ongoing oversite, maintenance, quality, and ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Attovia Therapeutics, Inc., is seeking a Clinical Trials Associate (CTA) to join our Clinical ... Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Attovia Therapeutics, Inc., is seeking a Clinical Trials Associate (CTA) to join our Clinical ... Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master ...
$25.75 - $35.25/hr
Our partner is looking for a Associate II, TMF Operations based in Netherlands. This role supports ... You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and ...
$25.75 - $35.25/hr
Our partner is looking for a Associate II, TMF Operations based in Netherlands. This role supports ... You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and ...
Clinical Trial Associate
Manhattan, NY · Remote
$55K - $65K/yr
Requirements Candidates should possess an Associate's or Bachelor's degree in one of the following ... Maintain and organize Trial Master File (TMF) documentation. * Assist with regulatory document ...
Quick apply
Clinical Trial Associate
Manhattan, NY · Remote
$55K - $65K/yr
Requirements Candidates should possess an Associate's or Bachelor's degree in one of the following ... Maintain and organize Trial Master File (TMF) documentation. * Assist with regulatory document ...
Associate Director, Trial Operations & Budget
Boston, MA · On-site
$150 - $190/hr
The Associate Director, Trial Operations & Budget is responsible for supporting the oversight ... Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and ...
Associate Director, Trial Operations & Budget
Boston, MA · On-site
$150 - $190/hr
The Associate Director, Trial Operations & Budget is responsible for supporting the oversight ... Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and ...
Associate Director, Trial Operations & Budget
Boston, MA · On-site
$123K - $154K/yr
The Associate Director, Trial Operations & Budget is responsible for supporting the oversight ... Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and ...
Associate Director, Trial Operations & Budget
Boston, MA · On-site
$123K - $154K/yr
The Associate Director, Trial Operations & Budget is responsible for supporting the oversight ... Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and ...
Associate Director, Trial Operations & Budget
Boston, MA · On-site
$123K - $154K/yr
The Associate Director, Trial Operations & Budget is responsible for supporting the oversight ... Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and ...
Associate Director, Trial Operations & Budget
Boston, MA · On-site
$123K - $154K/yr
The Associate Director, Trial Operations & Budget is responsible for supporting the oversight ... Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and ...
Sr. Clinical Trial Associate
$32 - $43.75/hr
SENIOR CLINICAL TRIAL ASSOCIATE Location: ONSITE - Miami, FL Overview of Role: The Senior Clinical ... Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems ...
New
Sr. Clinical Trial Associate
$32 - $43.75/hr
SENIOR CLINICAL TRIAL ASSOCIATE Location: ONSITE - Miami, FL Overview of Role: The Senior Clinical ... Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems ...
New
Sr. Clinical Trial Associate (Hybrid - Acton, MA)
Acton, MA · On-site
$37 - $50.25/hr
Job Summary The Clinical Trial Associate (CTA) is a core member of the Clinical Affairs team and is ... Trial Master File (TMF) & Documentation • Own the ongoing oversite, maintenance, quality, and ...
Sr. Clinical Trial Associate (Hybrid - Acton, MA)
Acton, MA · On-site
$37 - $50.25/hr
Job Summary The Clinical Trial Associate (CTA) is a core member of the Clinical Affairs team and is ... Trial Master File (TMF) & Documentation • Own the ongoing oversite, maintenance, quality, and ...
Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the ... Mentor Associate Clinical Trial Managers, Clinical Trial Specialists, and other Clinical Operations ...
Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the ... Mentor Associate Clinical Trial Managers, Clinical Trial Specialists, and other Clinical Operations ...
The In-House Clinical Research Associate is responsible for supporting clinical study teams ... Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI ...
The In-House Clinical Research Associate is responsible for supporting clinical study teams ... Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI ...
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?
| Aspect | Trial Master File Associate | Clinical Trial Coordinator |
|---|---|---|
| Certifications | May require GCP or regulatory document management certifications | Often requires GCP training, clinical research certifications |
| Work Environment | Focuses on document management within clinical trials | Oversees trial operations, patient coordination, site management |
| Industry Usage | Commonly used in pharmaceutical and biotech companies | Used 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.
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Job description
Company Description
A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
The primary purpose of this job is to file, QC, and remediate Medical Writing documentation required for Trial Master Files.
Uploads/files/performs quality control on documents to be submitted to the Trial Master File. Includes identification of missing documentation and follow-up with authors or other stakeholders to obtain missing items; performing quality reviews of files and any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies); and completing file review documentation.
Responsible for ensuring timely filing of TMF documentation; addressing backlog of unfilled documentation; performing periodic review and remediation of TMF.
Related Document Processing experience with Associate s degree
2+ yrs. with Bachelor's degree
Quality control experience preferred
Qualifications
Trial Master File, Documentation
Additional Information
Anuj Mehta
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(W) 732-429-1916 | (F) 732-549-5549
About Integrated Resources
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Edison, NJ, US
Year founded
1996