Covance CRA I or CRA II - Denmark in Copenhagen, Denmark
Covance is looking for a CRA 1 or CRA 2 to be client dedicated with a top 10 pharmaceutical company in Denmark. We can consider either full time or part time (0.5 FTE), ideally to start as soon as possible.
We can offer a permanemt contract or potentially freelance for the right individual and you can be home based or office based in centralCopenhagen. Therapeutic areas include Oncology, Diabetes, cardio and rare diseases.
Performs/participates in study site selection visits in the investigational sites
Performs Primary CRA function for eCRF studies during the set-up phase
Prepares/collects all study site essential documents needed prior to study initiation in collaboration with the Clinical Project Assistant (CPA) and Start-Up/Regulatory Team
Facilitates negotiation of site Clinical Trial Agreements (CTA) prepared by the Regional/Local Clinical Project leader (RCPL) or Start-Up/Regulatory Team
Ensures that sites apply for and receive hospital/practice/institution approval (e.g. R&D).
Organises/participates in study initiation meetings in which are provided scientific and technical knowledge concerning the study procedures and its organisation
Works with RCPL, Lead CRA and CPA to prepare, organise and participate in investigator meetings.
Assists the RCPL/CPA in maintaining and ensuring the completeness of the local study files, checking the country-level (when Lead CRA for studies with regional CPL) and centre-specific files at regular intervals and reconciling with the investigator study files
To apply for this position please email your CV toandy.smithor for a confidential discussion please call Andy on + 44 1635 253 724
Education / Qualifications
Appropriate education (life science degree / nursing qualification)
Candidates must be an experienced CRA with at least 1 years’ monitoring experience
Knowledge of and experience with GCP and other regulations in force; ability to learn and apply SOPs
Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting
Job Number 2018-23398
Job Category Clinical Research Associates
Position Type Full-Time
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.