Senior Project Coordinator
hace 2 días
The Senior Project Coordinator plays a crucial role in the success of our clinical trials, working closely with Project Managers, Clinical Trial Managers, and other stakeholders to ensure seamless site activation and maintenance.
Key Responsibilities:- Prepare Investigator Sites for clinical trials by reviewing and approving essential documents.
- Establish site activation timelines and coordinate activities to meet planned targets.
- Communicate with clinical sites during site start-up and collaborate with other departments to ensure alignment of activities.
- Escalate risks to site activation schedules and communicate directly with study teams and external site staff.
- Collect, review, and file essential documents, ensuring completeness and quality for successful first-pass review.
- Maintain the electronic Trial Master File (eTMF) and collect and distribute documents from/to sites.
- Produce meeting minutes and maintain ADI logs, assigning documents for internal project-specific training and coordinating reconciliation and documentation.
- Assist with drafting study documents and study plans, and act as the main point of contact for site correspondences.
- Support local ethics submissions, assist internal and external teams with access to study-specific systems, and assist with initiating and maintaining study files.
- Prepare shipments of study supplies to clinical sites and assist with preparation of Investigators' Meetings.
- Maintain project timeline dates, enrolment tracking tools, and study material inventory.
This role requires a minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research, with proven Site Start-Up experience in managing clinical trials and/or staff in a global/multi-regional environment.
We are looking for a motivated and detail-oriented individual who is passionate about project administration and clinical research, with excellent communication and organizational skills.
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