Covance Clinical Research Associate II in Warsaw, Poland
Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of ground-breaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.
We are now recruiting for CRA II to join our Clinical Operations team in Poland
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 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
- University degree in life sciences (preferably in pharmacy), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
2 years of Clinical Monitoring experience
Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Advanced site monitoring skills
Advanced study site management skills
Advanced 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
Advanced verbal and written communication skills
Ability to train and supervise junior staff
Ability to resolve project-related problems and prioritizes workload for self and team
Ability to work within a project team
Works efficiently and effectively in a matrix environment
Valid Driver's License
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.