Clinical Trial Coordinator
hace 2 semanas
Role Overview
The Senior Project Coordinator is a key member of the clinical trial team at Innovaderm Research, working closely with Project Managers, Clinical Trial Managers, Site Selection Team, and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site-level deliverables through all phases of the clinical trial lifecycle.
As a Senior Project Coordinator, you will be responsible for ensuring that timeframes, targets, and the quality of deliverables are in line with internal and external customer expectations. You will work autonomously to ensure optimized site activation and maintenance and may be asked to mentor junior project coordinators.
This role is ideal for individuals with a minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry. You will have proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment. You should have an interest in project administration and clinical research. Additionally, you will want to have an impact in a fast-growing company.
Key Responsibilities
- Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
- Establish site activation timelines with selected sites and coordinate activities to meet planned activation timelines.
- Communicate with clinical sites during site start-up.
- Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
- Escalate to the Project Manager risks to site activation schedule.
- Communicate directly with the study teams, external site staff to ensure tasks and priorities are aligned to the defined study timelines.
- Collect, review, and file sites essential documents.
- Ensure essential documentation is complete and of good quality to successfully first pass review for site activation.
- Ensure that the electronic Trial Master File (eTMF) contains the 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.
- Acts as a 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.
- Prepares shipments of study supplies to clinical sites, when applicable.
- Assist with preparation of Investigators' Meeting
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