Covance FSP are looking to hire a CRA I *based preferably in MILAN OR ROME but we can consider also other well connected locations* 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)
- *CRA certification* and some clinical trials experience Experience:
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Ability to resolve project-related problems and prioritize workload for self and team REMOTE - HOME BASED