[Hiring] Clinical Trial Associate @Parexel

Role Description

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.

• 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, identify and address study-related issues.
• Perform routine quality checks on trial level documents to ensure completeness and accuracy.
• Support 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.

Qualifications

• 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.

Company Description