Clinical Research Associate - Melanoma
covance
Madrid, Spain
hace 3 días

Job Overview :

Discover new opportunities to grow your career as a Covance FSP Clinical Research Associate.

Covance FSP are looking to hire a CRA II or Senior CRA I in Spain. In this position you will be fully dedicated to our sponsor and will be home based.

At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.

Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.

Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.

With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

Responsibilities include :

  • All details of site management as prescribed in the project plans
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
  • Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
  • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
  • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
  • Education / Qualifications :

  • University degree in life sciences (preferrably in pharmacy), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
  • Experience :

  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
  • Previous experience in monitoring studies in melanoma required
  • Excellent understanding of Serious Adverse Event (SAE) reporting
  • Ability to resolve project-related problems and prioritize workload for self and team
  • You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
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