Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Clinical Trial Associate - FSP - East Coast US
Job ID R0000039937Job 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, 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
- 1+ years experience supporting clinical operations activities in sponsor company or 2 years experience experience supporting clinical operations activities 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
- Foundational experience with eTMF systems and basic knowledge of essential documents to file study documents accurately with guidance
- Effective written and verbal communication skills, with the ability to work collaboratively within study teams
- Strong organization and interpersonal skills
- 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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