Clinical Trial Associate / Senior Project Specialist - East Coast US - 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.

Candidates must be East Coast US based.

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 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.  

Skills and Experience Required:

• BS/BA degree or degree in healthcare field required 

• Experience supporting clinical operations activities in a similar role, 1+ years in a pharma or biotech organization or 2 years of experience in a CRO environment  

• Basic knowledge of drug development and clinical operations processes 

• Foundational knowledge of clinical trial process and supports study activities in accordance with ICH-GCP and Code of Federal regulations  

• 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 (VeevaVault preferred) 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  

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.