Clinical Trial Associate - East Coast - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Summary:
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.

Key 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.  

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  

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EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.