Clinical Research Coordinator

hace 4 días

Madrid, Madrid, España Innovaderm Research A tiempo completo
Job Title: Clinical Research Coordinator

We are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Innovaderm Research. As a Clinical Research Coordinator, you will play a critical role in the success of our clinical trials by providing administrative and coordinating support to our project managers, clinical trial managers, and site selection team.

Key Responsibilities:
  • Prepare investigator sites for clinical trials by reviewing and approving 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 ensure alignment of activities to meet site activation targets.
  • Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
  • Escalate risks to site activation schedule to project managers.
  • Communicate directly with study teams and external site staff to ensure tasks and priorities are aligned to defined study timelines.
  • Collect, review, and file essential documents from sites.
  • Ensure essential documentation is complete and of good quality to successfully pass first review for site activation.
  • Ensure the 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 investigator 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.
About Innovaderm Research

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We have a solid reputation for the quality of our research and services, and we continue to grow and expand in North America and Europe. We are committed to providing equitable treatment and equal opportunity to all individuals, and we will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

We offer a stimulating work environment, attractive advancement opportunities, and a company 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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