Clinical Trial Coordinator

hace 1 semana

Madrid, Madrid, España Innovaderm Research A tiempo completo

Job Summary

The Clinical Trial Coordinator will work closely with Project Managers, Clinical Trial Managers, and Site Selection Team 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 key member of the project team, you will ensure that timeframes, targets, and the quality of deliverables are in line with internal and external customer expectations.

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 and 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 and communicate directly with the study teams and external site staff to ensure tasks and priorities are aligned with the defined study timelines.
Collect, review, and file sites' essential documents and 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, and maintain ADI log.
Assign documents for internal project-specific training and coordinate training reconciliation and documentation, and may assist with drafting of study documents and study plans for clinical trials.
Act as a main point of contact for all site correspondences for non-protocol related issues, assist sites with local ethics submissions, and assist internal and external teams with access to study-specific systems.
Assist with initiating and maintaining study files, assembling and shipping the Investigator's Study File, and maintaining project timeline dates, enrollment tracking tools, and study material inventory.
Prepare shipments of study supplies to clinical sites, when applicable, and assist with preparation of Investigators' Meeting.
Distribute study correspondence to sites, serve as in-house contact to support CRAs when traveling, and review and reconcile investigators' site and vendor payments.
Assist with project tracking activities and status reports preparation, and participate in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.

About Innovaderm Research

Innovaderm Research is a fast-growing company that values collaboration and impact. We are committed to providing administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle.

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