Senior Clinical Research Associate-FSP
2 weeks ago
About the Role:
Parexel is seeking a highly skilled and experienced Senior Clinical Research Associate-FSP to join our team. As a Senior Clinical Research Associate-FSP, you will be responsible for managing clinical trials from site identification to close-out, ensuring timely and accurate completion of project goals.
Key Responsibilities:- Manage clinical trials from site identification to close-out, ensuring timely and accurate completion of project goals.
- Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
- Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
- Ensure that assigned sites are audit and inspection ready.
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
- Show commitment and perform consistent high quality work.
- Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
- Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
- Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
- Provide input and feedback for Performance Development Conversation(s).
- Proactively keep manager informed about work progress and any issues.
- Develop expertise to become a subject matter expert.
- Work in a self-driven capacity, with limited need for oversight.
- Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
- Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
Parexel offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Senior Clinical Research Associate-FSP looking for a new challenge, please apply today
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