1

Trial Master File Associate Jobs in California (NOW HIRING)

Sr CTA - Autoimmune

San Diego, CA ยท On-site

$35 - $48/hr

The Senior Clinical Trial Associate supports the operational execution of clinical studies by ... Maintain and organize Trial Master File (TMF) documentation and track essential study records.

Associate's or Bachelor's degree in a related field. Skills: * Clinical research. * Process improvement. * Trial Master File (TMF). * Inventory management. * Sunshine Act compliance. * Invoice ...

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 ...

Sr. Clinical Trial Manager

San Diego, CA ยท On-site

$175 - $200/hr

The Associate Director, Clinical Operations will be responsible for managing operational aspects of ... Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF)

Clinical Research Associate II

Alameda, CA ยท 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 ยท 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 ...

Associate's or Bachelor's degree in a related field. Skills: Clinical research. Process improvement. Trial Master File (TMF). Inventory management. Sunshine Act compliance. Invoice processing. Record ...

Showing results 21-40

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 California?

The most popular types of Trial Master File jobs in California are:

What are popular job titles related to Trial Master File Associate jobs in California?

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

What cities in California are hiring for Trial Master File Associate jobs?

Cities in California with the most Trial Master File Associate job openings:

Clinical Project Associate

Integrated Resources INC

Foster City, CA โ€ข On-site

$39 - $53.25/hr

Contractor

Re-posted 8 days ago


Job description

Company Description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Project involvement will be in an administrative role.
Provides administrative support to the Clinical Operations function including set-up, maintenance and reconciliation of the Trial Master File (including RDMS) for studies on an as needed basis.
The position entails work under general supervision for routine tasks and with detailed instructions on new assignments.
Tracking and preparing study-specific information utilizing databases (GILDA, DataVision), spreadsheets, and other tools.
Distributes updated study related documents (i.e. Investigative Brochures, package inserts) to study teams and internal departments as requested by the CTMA or CTM.
Under close supervision reviews and participates in the quality assurance of data or documents including and not limited to GILDA and DataVision.
Arranges meeting logistics.
Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks).

Qualifications

Typically requires a BS or BA in a relevant scientific discipline.
2+ years of experience and an Associate's degree.
Must be familiar with Word, Outlook, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.


Skills/Experience requirements:
Excellent verbal and written communication skills and interpersonal skills are required.
Must be able to work both independently and as part of a team.

Additional Information

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.


Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (732)-844-8715

Gold Seal JCAHO Certified for Health Care Staffing

"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)


Integrated Resources logo

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