Senior Clinical Research Associate home based in Oslo area
Location: Oslo, Norway
Closing Date: 14 Dec 16
Salary (£): Competitive
Covance current growth of Clinical Development Services (CDS) in Scandinavian countries brings new opportunities not only for clinical roles, but also another business functions. At the moment we are looking for Clinical Research Associates (CRA) / Senior Clinical Research Associates (SCRA).
Main Job Responsibilities:
- All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
- Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
- Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
- Completing Serious Adverse Event (SAE) reporting, processing production of reports;
- Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned;
- Interact with internal work groups to evaluate needs, resources and timelines;
- Assist with training, mentoring, and development of junior employees, e.g. co-monitoring;
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
- Degree educated (Life Science)
- Few years of relevant clinical research experience in pharmaceutical or CRO industries
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Excellent site monitoring skills
- Excellent study site management skills
- Excellent registry administration skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Excellent verbal and written communication skills
- Ability to resolve project-related problems and prioritizes workload for self and team
- Fluent Norwegian and English language skills
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.