Covance

Clinical Research Associate II/ Sr CRA, Estonia

Company
Covance
Salary
Competitive
Posted
16 Nov 2018
Closes
16 Dec 2018
Ref
CRA, EST

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 cooperation 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

Requirements:

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
  • Proven on-site Clinical Monitoring experience
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
  • Thorough knowledge of monitoring procedures
  • Basic understanding of the clinical trial process
  • 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
  • You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.