Candidates with a varied therapeutic area background are encouraged to apply. You will work on exciting studies for some of the world’s largest pharmaceutical companies and support project management as Lead CRA on projects.
With diverse monitoring experience the successful candidate will also be able to perform additional project supporting functions such as monitoring report template/annotation prep, review of project plans, co-monitoring, site feasibility/selection activities, presentation at investigator meetings and acting as Lead CRA on projects.
Key responsibilities will include:
Developing, implementing and maintaining study documents, timelines, report formats, files, communication tools, budgets, and systems used in conducting a project
Provide clear communication between levels of project: from team, to site and report to overall project leaders
Perform routine site visits, including Pre-Study, Initiation, Routine and Closeout visits,compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance
Assist Project Managers in study execution by acting as Lead CRA on projects andfacilitating communication with Clinical Monitoring team
Participate in TMF and on-site audits as requested
Responsible for site management and site staff performance
Participate in company-required training programs
Participate on BID defense meeting
Performs clinical data listings reviews as needed
Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution
Provide a high level of administrative functions to assure smooth project running
To be successful, the requirements for this opportunity include:
Bachelor degree in life sciences, pharmacy, registered nursing or equivalent
A minimum of 1-3 years’ experience in clinical research
Proven ability to work independently in a fast-paced environment
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Strong communication skills with the ability to build strong internal and external relationships
Fluency in Italian and a high level of English language are required
If this sounds appealing to you, please contact Franzi Dunker via email firstname.lastname@example.org or via phone +49 69 274 015 840. The applications will be handed with discretion.