Clinical Trial Assistant

The Clinical Trials Assistant (CTA) will be responsible for providing operational/administrative support to the Clinical Affairs team for the daytoday 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 of all study activities. The CTAs main responsibilities are to maintain the studys Electronic Trial Master Files (eTMF) ensure quality and track the status of study documents  studyspecific training for team members and study sites capture studyspecific meeting minutes produce studyspecific binders and interface with study vendors and site study staff.

What you will be responsible for: 

• Assist in the planning coordination and of clinical trials to ensure compliance with FDA Regulations ICHGCP Guidelines and company SOPs.
• Manage  clinical trials Electronic Trial Master File (eTMF) and Investigator Site File (ISF) including setup 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 studyspecific 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 healthrelated discipline is strongly preferred with 02 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.

Treaces Privacy Policy

It is Treaces 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.

Remote Work :

No

Employment Type :

Fulltime