Clinical Trial Associate - East Coast - FSP

Parexel•Southport, NC

About The Position

The Clinical Trial Associate (CTA) provides operational and administrative support to clinical trials throughout their lifecycle, ensuring consistency with applicable regulatory guidelines (ICH-GCP, client’s SOPs) and facilitates smooth execution of trial activities. Study management activities may include maintenance of information databases and trial tracking reports, coordination of clinical trial documentation and general support to ensure the successful and timely execution of clinical activities and deliverables.

Requirements

BS/BA degree or degree in healthcare field required
Direct experience supporting clinical operations activities, 1+ years in pharma/biotech company or 2+ years of experience in a CRO
Very strong foundational understanding of clinical trials, and have prior experience in the administrative aspects of clinical operations
Experience managing the TMF with a solid understanding of filing expectations at study, country, and site levels
Experience managing the CTMS, study team lists, SharePoint accesses
Taking diligent meeting agendas/minutes
Tracking and following up on action items with a fundamental understanding what goes into each action
Tracking study plans & training compliance
Maintaining ongoing systemic reviews, such as User Access Reviews, eSystems List Reviews, Global Vendor Listing Reviews
Effective written and verbal communication skills, with the ability to work collaboratively within study teams
Strong organization and interpersonal skills
Foundational experience with eTMF systems and basic knowledge of essential documents to file study documents accurately with guidance
Strong attention to detail
Able to prioritize and manage multiple tasks with competing deadlines
High sense of urgency and commitment to excellence in the successful execution of deliverables
Demonstrates ability to identify issues and escalate appropriately to support timeline adherence
Proficient with MS Office Suite (Excel, Word, PowerPoint) and project tracking tools

Responsibilities

Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
Set up, organize and maintain study files and shared spaces in accordance with study requirements
Coordinate and track study training
Manage study sample and supply tracking and support interactions with vendors as needed
Support the Study Management team with specific projects
Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-related issues
Perform routine quality checks on trial level documents to ensure completeness and accuracy
Supports the timely, complete and compliant archiving in the TMF
Participate in company, departmental and project team meetings including Investigator Meetings
May assist with basic financial and budget tracking activities related to the clinical trial.