Senior CRA Italy, Oncology Lead CRA duties

Job Type:
Clinical Research
Job Category:
Salary Description:
Job Ref:

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 or via phone +49 69 274 015 840. The applications will be handed with discretion.


Contact Details:
Tel: +49 69 274 015 840
Contact: Franzi Dunker

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