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Trial Master File Associate Jobs in Clifton, NJ (NOW HIRING)

Cellectis

Clinical Trial Associate

Manhattan, NY

$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)

Cellectis

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)

Allen Spolden

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 ...

Ptc Therapeutics, Inc.

Clinical Trial Associate I

Warren, NJ · On-site

$34.75 - $47.50/hr

The Clinical Trial Associate I (CTA) is a key support role within the Clinical Operations ... Supports the set-up, organization, and maintenance of the Trial Master File (TMF), ensuring ongoing ...

Axsome Therapeutics

Clinical Trial Associate

New York, NY · On-site

$60K - $66K/yr

About This Role Axsome Therapeutics is seeking a Clinical Trial Associate (CTA) that is responsible ... Review and maintain documents in the Electronic Trial Master File (eTMF) * Assist clinical study ...

IQVIA Argentina

CRA 2, Oncology, IQVIA

Wayne, NJ · On-site

$87.20 - $145.30/hr

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 ...

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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.

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

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

The top searched job categories for Trial Master File Associate jobs in Clifton, NJ are:

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Cities near Clifton, NJ 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 Clifton, NJ as of August 2026, with employment types broken down into 72% Full Time, and 28% Contract. Highlights an 66% In-person, and 34% Remote job distribution.

Clinical Trial Associate

Cellectis

Manhattan, NY

$36.75 - $50.25/hr

Full-time

Re-posted 27 days ago

Job description

The Clinical Trial Associate (CTA) supports clinical study teams in the execution and oversight of clinical trials under the direction of the Vice President, Development Operations, with day-to-day guidance from the assigned Study Lead. The CTA plays a key role in study start-up, ongoing trial execution, and close-out activities, with a primary focus on document management, trial tracking, and operational support.

This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance with applicable regulatory requirements (GCP/ICH), internal SOPs, and company standards.

All activities are conducted in accordance with company policies, SOPs, and corporate values.

POSITION RESPONSIBILITIES

Clinical Trial Support

  • Support study start-up activities, including site feasibility, investigator onboarding, and collection of regulatory and essential documents
  • Assist with site management activities throughout the trial lifecycle, from start-up through close-out
  • Communicate with clinical sites and vendors, as appropriate, to support timely collection of required documentation
  • Support investigational product tracking activities, including inventory documentation, shipment tracking, and reconciliation

Trial Documentation & Systems

  • Maintain accurate, complete, and inspection-ready Trial Master Files (electronic or paper)
  • Support ongoing maintenance of the Clinical Trial Management System (CTMS), ensuring data accuracy and timeliness
  • Review, file, and track clinical trial documentation in accordance with SOPs and regulatory requirements
  • Assist with quality control (QC) checks of study, country, and site-level documentation and support issue resolution

Study Tracking & Reporting

  • Maintain study trackers (e.g., regulatory submissions, site start-up timelines, protocol issue logs)
  • Track study progress and generate routine status reports and metrics as requested
  • Assist with review of monitoring visit reports (initiation, routine monitoring, and close-out)

Meetings & Cross-Functional Collaboration

  • Coordinate and support internal and external study meetings, including preparation of agendas, meeting minutes, and action item tracking
  • Collaborate with cross-functional teams, CROs, and vendors to support routine study operations
  • Provide general administrative and operational support to Development Operations team as needed

Compliance & Inspections

  • Support preparation for and follow-up on audits and regulatory inspections, as applicable
  • Assist with review of informed consent documents, case report forms, and other study-related materials

EDUCATION AND EXPERIENCE

  • Bachelor's degree (BS/BA) or equivalent preferred
  • Minimum of 1-3 years of experience supporting clinical trials, preferably in a pharmaceutical, biotechnology, or CRO environment

TECHNICAL SKILLS & CORE COMPETENCIES

  • Foundational knowledge of FDA and/or EMA regulations, ICH guidelines, and GCP requirements
  • Basic understanding of clinical trial documentation, filing structures, and operational workflows
  • Working knowledge of clinical systems such as eTMF, CTMS, and EDC platforms
  • Ability to manage multiple tasks and priorities in a fast-paced clinical development environment
  • Strong attention to detail and organizational skills
  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
  • Effective written, verbal, and interpersonal communication skills
  • Ability to work collaboratively across functions with appropriate supervision and guidance

Proposed Compensation Range: 80,000 - 90,000

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