ZipRecruiter

Log In

1

Trial Master File Associate Jobs in Florida (NOW HIRING)

IQVIA

Sr. Clinical Research Associate, IQVIA

Tampa, FL

$101K - $169K/yr

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

Sr. Clinical Research Associate, IQVIA

Tampa, FL

$101K - $169K/yr

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

Sitero LLC

Director, Business Development

Miami, FL · On-site

... Trial Master File (eTMF), clinical trial management systems (CTMS), RTSM, Patient Payments ... Sitero is seeking a high-performing, strategically minded Business Development Associate (BDA) with ...

Sitero LLC

Director, Business Development

Miami, FL · On-site

... Trial Master File (eTMF), clinical trial management systems (CTMS), RTSM, Patient Payments ... Sitero is seeking a high-performing, strategically minded Business Development Associate (BDA) with ...

next page

Showing results 1-20

People also search for

All JobsTrial Master File Associate JobsTrial Master File Associate Jobs in Florida

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 the most commonly searched types of Trial Master File jobs in Florida? The most popular types of Trial Master File jobs in Florida are:
What are popular job titles related to Trial Master File Associate jobs in Florida? For Trial Master File Associate jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Florida look for? The top searched job categories for Trial Master File Associate jobs in Florida are:
What cities in Florida are hiring for Trial Master File Associate jobs? Cities in Florida with the most Trial Master File Associate job openings:
Trial Master File Associate jobs near you

Clinical Trial Administrator

Quotient Sciences

Miami, FL • On-site

Full-time

Posted 5 days ago

Job description

Quotient Sciences: Molecule to Cure. Fast.
Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.
Our proprietary and disruptive platform - "Translational Pharmaceutics®" - integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.
Why join us:
Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast.
The Role
  • Responsible to provide administrative support for the Project Management group and to lead the study review activities and communications on allocated projects
  • To comply & adhere to GCP guidelines and regulations as required of this role

Main Tasks and Responsibilities
  • Assist in the preparation and formatting of study documentation, including informed consent forms, source documents, and client deliverables.
  • Establish and maintain study files, including Trial Master Files (TMF) in both electronic and paper formats.
  • Maintain delegation logs by coordinating with internal teams to ensure accuracy and timely updates for new and terminated staff.
  • Maintain training logs and ensure training compliance for all personnel listed on delegation logs.
  • Manage file note control, including creation, review, and filing.
  • Ensure all regulatory documentation is audit-ready and compliant with archiving requirements.
  • Support study review board submissions by uploading administrative documents, study updates, and required correspondence.
  • Process Spanish regulatory documents and communicate approvals to the screening team.
  • Notify staff of updated or newly released documents via secure file systems.
  • Support the Project Management team with PSA activities, revenue forecasting, and invoicing.
  • Assist with study closeout activities, including budget reconciliation and archiving.
  • Maintain and perform quality control (QC) of the volunteer clinical RSVP database.
  • Manage laboratory requisitions and collaborate with Data Management to support query resolution.
  • Support eSource User Acceptance Testing (UAT) activities.
  • Assist with the hosting and support of sponsor monitors during site visits and with related action items

Job Demands
  • The job may involve the following:
    • Very high concentration of work
    • Strict and tight deadlines
    • Having to juggle a range of tasks/issues simultaneously
    • Working in a hazardous environment with high requirement to follow safety procedures
    • Working outside normal working hours
    • Needing to respond to client demands

The Candidate
  • Minimum Degree qualification or equivalent
  • Relevant work experience in a pharmaceutical company/CRO would be an advantage
  • Computer literate, proficient in Microsoft Windows
  • Proficient in Information Technology
  • Highly organized and efficient
  • Ability to communicate effectively; people-oriented personality

Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

Apply