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Clinical Trial Assistant

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Job Description

The Clinical Trials Assistant (CTA) will be responsible for providing operational/administrative support to the Clinical Affairs team for the day-to-day execution of clinical trials. The position will assist in organizing different stages of clinical trials following established SOPs, Good Clinical Practice (GCP) and applicable regulatory regulations in the execution of all study activities. The CTA’s main responsibilities are to maintain the study’s Electronic Trial Master Files (eTMF), ensure quality, and track the status of study documents, study-specific training for team members and study sites, capture study-specific meeting minutes, produce study-specific binders, and interface with study vendors and site study staff.

What you will be responsible for:

Assist in the planning, coordination, and execution of clinical trials to ensure compliance with FDA Regulations, ICH-GCP Guidelines, and company SOPs.
Manage clinical trials Electronic Trial Master File (eTMF) and Investigator Site File (ISF) including set-up of eTMF, collection of clinical trial documents, QC and review of all study specific documents received from study sites and CRA(s), filing, and ensuring all files are up to date and accurate.
Ensure eTMF is audit and inspection ready.
Manage radiographic images completed for clinical trials, including collection, review, and working with outside radiologist(s) on reads, managing radiographic vendors, and providing radiographic data to internal stakeholders.
Assist with study document processing, including review and QC, formatting study documents, and assisting with other reviews as requested.
Prepare and maintain study specific Regulatory Binders and Subject Binders for delivery to study sites.
Coordinate archiving of completed studies.
Assist with study site communication and tracking study progress.
Maintain, prepare, and distribute study materials such as Instructions for Use, protocols, informed consent forms, study manuals, source document worksheets, and any other study materials as requested.
Maintain study-specific training documentation for Clinical Affairs and Study Site teams, ensuring appropriate documentation is obtained and filed.
Coordinate Institutional Review Board (IRB) submissions and approvals.
Contribute to the preparation of study reports, regulatory submissions, presentations, and posters as requested.
Schedule and participate in weekly team meetings, prepare, and distribute meeting agendas, materials, and minutes.
Assist with scheduling monitoring visits on team calendar.
Assist with user acceptance testing of clinical study electronic data capture system(s).
Supports maintenance of department SOPs and work instructions.
Complete other tasks and projects assigned by the Clinical Project Manager and/or Director, Clinical Affairs.
Ensure all study activities are conducted in compliance with Good Clinical Practice (GCP) Guidelines

Qualifications

BS or BA degree in a medical, scientific, or health-related discipline is strongly preferred, with 0-2 years of related clinical experience. In lieu of degree, a HS Diploma with 3+ years of clinical experience is required.
Ability and willingness to travel (up to 15%)

Additional Information

All your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer

Treace is a drug free employer.

Average salary estimate

$50000 / YEARLY (est.)

min

max

$40000K

$60000K

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What You Should Know About Clinical Trial Assistant , Treace

The Clinical Trial Assistant (CTA) at Treace in Ponte Vedra, Florida, is an essential part of the Clinical Affairs team, providing operational and administrative support for our clinical trials. This role is crucial in ensuring the efficient execution of clinical trials while adhering to established Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and relevant regulatory guidelines. As a CTA, you'll be tasked with maintaining our Electronic Trial Master Files (eTMF), keeping study documents accurate and up to date, and ensuring they are audit and inspection ready. You'll coordinate training for team members and study sites, capture meeting minutes, and work closely with various vendors and site staff. Your dedicated efforts will help assure compliance with FDA Regulations and ICH-GCP Guidelines, making you a vital contributor to our projects. From managing clinical documentation to assisting with the planning and execution of study-specific materials, every day brings new challenges and opportunities for growth. If you're excited about contributing to groundbreaking clinical research and supporting a purposeful cause, then this role with Treace might just be your calling. Join us as we advance medical research and improve patient care. Your journey in clinical trials starts here!

Frequently Asked Questions (FAQs) for Clinical Trial Assistant Role at Treace

What are the key responsibilities of a Clinical Trial Assistant at Treace?

As a Clinical Trial Assistant at Treace, your main responsibilities include maintaining the Electronic Trial Master Files (eTMF), assisting in organizing clinical trials, capturing meeting minutes, producing study-specific binders, and communicating with study vendors and site personnel. Ensuring compliance with regulatory norms and supporting the Clinical Affairs team is at the heart of this role.