Clinical Research Associate II - Riga, Latvia
Clinical Research Associates – LATVIA
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 succesful candidate will be office-based at Client's in Riga.
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..
- 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 Latvia
- Fluency in both English and local language
- Diabetes/cardiovascular TA experience preferable
- Skills in building relationship with customer
- Flexible in travelling (2-3 days/week)
- Service minded
- Team player
As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
- 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
At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
We welcome your application and believe this decision may be the most rewarding career move you will ever make!
This job was originally posted as www.emedcareers.com/job/960521402