Project Coordinator
4 weeks ago
We are seeking a highly organized and detail-oriented Project Coordinator to join our team at Innovaderm Research. As a Project Coordinator, you will play a key role in supporting the activation of clinical trial sites and ensuring the successful execution of research projects.
Key Responsibilities- Prepare clinical trial sites for activation by reviewing and approving essential documents
- Establish site activation timelines and coordinate activities to meet planned timelines
- Communicate with clinical sites during site start-up and ensure alignment of activities with study timelines
- Collaborate with other functional departments to ensure alignment of activities and meet site activation targets
- Escalate risks to site activation schedule to Project Managers
- Collect, review, and file essential site documents
- Ensure electronic Trial Master File (eTMF) contains relevant regulatory documents for site activation and ongoing study management
- Collect and distribute documents from/to sites
- Produce meeting minutes from project meetings
- Maintain ADI log
- Assign documents for internal project-specific training and coordinate training reconciliation and documentation
- May assist with drafting of study documents and study plans for clinical trials
- Act as main point of contact for all site correspondences for non-protocol related issues
- Assist sites with local ethics submissions
- Assist internal and external teams with access to study-specific systems
- Assist with initiating and maintaining study files
- Assist with assembling and shipping the Investigator's Study File
- Maintain project timeline dates, enrolment tracking tools, and study material inventory
- Prepare shipments of study supplies to clinical sites, when applicable
- Assist with preparation of Investigators' Meeting
- Distribute study correspondence to sites
- Serve as in-house contact to support CRAs when traveling
- Review and reconcile investigators site and vendor payments
- Assist with project tracking activities and status reports preparation
- Participate in various administrative tasks as required to accomplish the goals of the project and the needs of the project team
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation & Corrective Action / Preventative Action preparation for project related issues
- May perform project management duties on designated trials
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. Our team is dedicated to providing high-quality research services to our clients, and we are committed to excellence in all aspects of our work.
We offer a stimulating work environment, attractive advancement opportunities, and a comprehensive benefits package. If you are a motivated and detail-oriented individual who is passionate about clinical research, we encourage you to apply for this exciting opportunity.
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