Senior Clinical Research Associate – SWEDEN
We are currently looking for talented Senior to work for us in the Co-source department as our sponsor, a well-known pharma company, is currently expanding their Clinical Operations team. This is a full-time, permanent and home-based positions nearby Stockholm; Sweden.
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 Sweden.
- 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 Sweden
- Several years of experience of monitoring in oncology (experience from immune oncology an advantage)
- Fluency in both English and Swedish
- Knowledge in the TA oncology - experience in additional TAs also favorable
- Proven skills in site management including site performance and patient recruitment
- Skills in building relationship with customer
- Flexible in travelling (2-3 days/week)
- Service minded
- Team player
- IT oriented
As a SCRA 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
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!