Job Description
Clinical Research Associates
We are currently looking for a talented Clinical Research Associate II to work for us in
the Co-source department as our sponsor, a well-known pharma company, is
currently expanding their Clinical Operations team. The role is full-time/permanent and
the successful candidate will be office-based at Client's in Riga.
Summary:
This is a CRA position available to work within our Phase II-IV CoSource division
directly with pharmaceutical company. As an experienced CRA you’ll be involved in initiation,
routine & close out visits concentrating on sites in Latvia.
Requirements:
- Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event reporting
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Germany
- Previous experience of leading/managing a CRA team
- Experience of reviewing CRA trip reports
- Fluency in speaking and writing both English and German
- Oncology experience
- Degree in life sciences OR equivalent experience in clinical monitoring
- At least 3-4 years experience in clinical monitoring, oncology experience preferred
- All aspects 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
- Management of administrative duties connected with assigned protocols