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 Manager
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Clinical Trial Manager
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Clinical Trial Manager
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Clinical Trial Manager
Berkeley, CA · On-site +1
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Clinical Trial Manager
Redwood City, CA · Hybrid
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Trial Manager
Redwood City, CA · Hybrid
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Trial Manager
Redwood City, CA · Hybrid
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Trial Manager
Redwood City, CA · Hybrid
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Project Associate
$39 - $53.25/hr
... Trial Master File (including RDMS) for studies on an as needed basis. The position entails work ... Associate's degree. Must be familiar with Word, Outlook, PowerPoint, and Excel. Knowledge of FDA ...
Clinical Project Associate
$39 - $53.25/hr
... Trial Master File (including RDMS) for studies on an as needed basis. The position entails work ... Associate's degree. Must be familiar with Word, Outlook, PowerPoint, and Excel. Knowledge of FDA ...
Clinical Project Associate
Foster City, CA · On-site
$39 - $53.25/hr
... Trial Master File (including RDMS) for studies on an as needed basis. The position entails work ... Associate's degree. Must be familiar with Word, Outlook, PowerPoint, and Excel. Knowledge of FDA ...
Clinical Project Associate
Foster City, CA · On-site
$39 - $53.25/hr
... Trial Master File (including RDMS) for studies on an as needed basis. The position entails work ... Associate's degree. Must be familiar with Word, Outlook, PowerPoint, and Excel. Knowledge of FDA ...
Clinical Trial Manager
Redwood City, CA · On-site
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Trial Manager
Redwood City, CA · On-site
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Records Associate
Foster City, CA · On-site
Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Participate in offsite storage activates. * Create and maintain study specific file structures for clinical ...
Clinical Records Associate
Foster City, CA · On-site
Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Participate in offsite storage activates. * Create and maintain study specific file structures for clinical ...
Salesforce Solution Architect and Lead Engineer for CTMS
San Jose, CA · On-site
$81.75 - $101.25/hr
Understanding of CTMS, eTMF (Electronic Trial Master File), and EDC (Electronic Data Capture) . * Working knowledge of 21 CFR Part 11 , GCP , and HIPAA regulations. * Experience integrating ...
Quick apply
Salesforce Solution Architect and Lead Engineer for CTMS
San Jose, CA · On-site
$81.75 - $101.25/hr
Understanding of CTMS, eTMF (Electronic Trial Master File), and EDC (Electronic Data Capture) . * Working knowledge of 21 CFR Part 11 , GCP , and HIPAA regulations. * Experience integrating ...
Clinical Records Associate
Foster City, CA · On-site
Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Participate in offsite storage activates. * Create and maintain study specific file structures for clinical ...
Clinical Records Associate
Foster City, CA · On-site
Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Participate in offsite storage activates. * Create and maintain study specific file structures for clinical ...
Clinical Trial Assistant
Foster City, CA · On-site
$75K - $90K/yr
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Clinical Trial Assistant
Foster City, CA · On-site
$75K - $90K/yr
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Clinical Trial Assistant
Foster City, CA · On-site
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Clinical Trial Assistant
Foster City, CA · On-site
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Clinical Trial Manager
Redwood City, CA · On-site
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Trial Manager
Redwood City, CA · On-site
... the Trial Master File (TMF). * Participation in team meetings and collaboration with other ... Research Associates (CRAs) assigned to clinical studies. * Preparation and tracking of study ...
Clinical Research Associate II
Alameda, CA · On-site
$81K - $141K/yr
As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...
Clinical Research Associate II
Alameda, CA · On-site
$81K - $141K/yr
As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...
Clinical Operations Manager
Martinez, CA · On-site
Assess Trial Master File(s) against applicable regulations and industry best practices. As needed remediate structure of Trial Master File(s) and as applicable records to ensure audit readiness ...
Quick apply
Clinical Operations Manager
Martinez, CA · On-site
Assess Trial Master File(s) against applicable regulations and industry best practices. As needed remediate structure of Trial Master File(s) and as applicable records to ensure audit readiness ...
Providing Clinical Research Associates with project-specific training, guidance, and oversight ... Ensures Trial Master File is maintained throughout the study * Practices professionalism and ...
Providing Clinical Research Associates with project-specific training, guidance, and oversight ... Ensures Trial Master File is maintained throughout the study * Practices professionalism and ...
Clinical Research Associate II
Alameda, CA · On-site
$81K - $141K/yr
As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...
Clinical Research Associate II
Alameda, CA · On-site
$81K - $141K/yr
As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...
Clinical Research Associate II
Alameda, CA · On-site
$81K - $141K/yr
As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...
Clinical Research Associate II
Alameda, CA · On-site
$81K - $141K/yr
As the Clinical Research Associate II, you will assist in the clinical execution and management of ... Maintain and audit Trial Master File to ensure inspection readiness. * Participate in cross ...
Clinical Trial Assistant
Sunnyvale, CA · On-site
$70K - $94K/yr
Establish, organize and maintain trial master file and clinical trial management system to ensure ... Collaborate with Clinical Research Associates (CRA), Clinical Study Managers (CSM) and Clinical ...
Clinical Trial Assistant
Sunnyvale, CA · On-site
$70K - $94K/yr
Establish, organize and maintain trial master file and clinical trial management system to ensure ... Collaborate with Clinical Research Associates (CRA), Clinical Study Managers (CSM) and Clinical ...
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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For Trial Master File Associate jobs in Pleasanton, CA, the most frequently searched job titles are:
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Job description
Company Description
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
Job Title: Clinical Records Associate - II
Location: Foster City, CA
Duration: 12 Months
Job Description:
- Must meet all requirements for Clinical Records Assistant position and have demonstrated proficiency in all relevant areas.
- Maintain an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records.
- Maintain a working knowledge of clinical, biometrics, and preclinical documents.
- Participate in continued security and maintenance of the Trial Master File (TMF) Room.
- Assist in the development and implementation of procedure s for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records.
- Assist in the development of Trial Master File SOPs.
- Assist with the training of Client and contract employees on the TMF SOPs.
- Participate in the management of vendor relationships including offsite storage.
- Create and maintain study specific file structures for Client clinical, biometrics, and preclinical documents and file documents accordingly.
- Ensure record filing is kept up to date and is performed accurately.
- Perform an inventory review for incoming CRO clinical study files; receive, index, and file preclinical study records; responsible for offsite archival of documents; participate in periodic file room utilization reviews; file incoming documents and retrieve documentation from the TMFR upon request.
- Ensure appropriate documentation completed to track archival of files.
- May provide support during TMF-related regulatory agency and internal GCP inspections.
- Assist in the development of electronic tracking/ filing systems.
Additional Information
Kind Regards,
Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Gold Seal JCAHO Certified for Health Care Staffing
"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)
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