Clinical Operations Coordinator
1 semana atrás
We are seeking a highly skilled Clinical Operations Coordinator to join our team at Thermo Fisher Scientific. This is an exciting opportunity for individuals who thrive in fast-paced environments and are passionate about delivering high-quality results.
About the RoleIn this role, you will be responsible for performing a thorough review of clinical monitoring visit reports for allocated projects, ensuring consistency across protocols and regions. You will also escalate any protocol, site, or CRA issues or trends noted during the report review process to the CTM. Additionally, you will liaise with clinical monitoring staff for prompt trip report review submission and approval as per PPD and/or sponsor stipulated timelines.
As a key member of the project team, you will contribute to ensuring compliance with monitoring visit report expectations. You will also review and customize Monitoring Report Templates for allocated projects and evaluate PI oversight (e.g., protocol adherence), subject safety, and study processes to assess site ability to conduct study.
You will attend applicable internal Project meetings and provide input on forecast estimates for report review activities. Furthermore, you will provide trial MVR status tracking and progress update reports to the team as required. In addition, you may contribute to company, client, and federal/local regulatory requirements/audit responses as needed.
Key Responsibilities- Review clinical monitoring visit reports for allocated projects
- Evaluate PI oversight, subject safety, and study processes
- Liaise with clinical monitoring staff for report review submission and approval
- Attend internal Project meetings
- Provide input on forecast estimates for report review activities
- Contribute to company, client, and regulatory requirements/audit responses
To succeed in this role, you should possess excellent communication and organizational skills, with the ability to work effectively in a team environment. You should also have strong attention to detail, analytical skills, and the ability to prioritize tasks and manage multiple projects simultaneously.
What We OfferAs a valued member of our team, you can expect a competitive salary of $80,000 - $110,000 per year, depending on experience, plus a comprehensive benefits package that includes medical, dental, and vision insurance, 401(k) matching, paid time off, and professional development opportunities.
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