Clinical Research Coordinator Senior

1 month ago

Cambridge, Cambridgeshire, United Kingdom Merus Netherlands Full time
Job Title: Clinical Research Coordinator, Sr

We are seeking a highly skilled and experienced Clinical Research Coordinator, Sr to join our Clinical Operations team at Merus Netherlands. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials, from planning to close-out.

Key Responsibilities:
  • Manage clinical trial deliverables, including contract research organizations (CROs), protocol and related documents, study tools, guidelines, and training materials.
  • Assist in authoring protocol and related documents, development of study tools, guidelines, and training materials.
  • Oversee vendors and other third parties, and assist in the implementation plan, risk management, oversight management plans, data review processes, TMF review plans, and execution.
  • Manage global clinical trial experience in Oncology across multiple countries/regions.
  • Lead internal Operations team meetings and co-lead Clinical Trial Team (CTT) meetings with the CRO.
  • Manage site-related issues and procedural questions, support Executive Director & Director of Clinical Operation development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, all plans, etc.
  • Participate in CRA calls to assist with site follow-up, recruitment, training, protocol deviation finding resolutions, trip report review findings, and overall CRA training.
  • Review of TMF and assistance with remediation of findings along with Clinical Trial Associates (CTAs).
  • Manage site engagement and site relationships through communications and visits with clinical sites and cross-functional collaboration with Medical Affairs and Clinical Development.
  • Participate in oversight monitoring visits at clinical trial sites.
Requirements:
  • Experience with cross-functional clinical trials, capabilities in supporting operational aspects of clinical trial-related activities (planning, executing, and reporting) as well as the clinical/scientific aspects.
  • Clinical Research Associate experience is strongly preferred and knowledge of how to conduct source data verification (SDV) and how to execute all types of monitoring visits – Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close Out Visits (COVs).
  • Knowledge of GCP (Good Clinical Practice), comprehensive knowledge of clinical trial design, and a good understanding of the overall drug development process.
  • Basic knowledge of oncology is preferred.
What We Offer:

We offer a competitive salary, flexible working hours, and a company bonus structure. Most importantly, you'll have the chance to help us close in on cancer – everything you do matters at Merus.

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