Senior Clinical Research Associate
4 days left
- Experience Level
- Experienced (non-manager)
An exciting home-based opportunity has arisen in Germany for a Senior and experienced CRA. This role includes performs monitoring to ensure that reported study data are accurate, complete and verifiable from source documents; and that the conduct of the study is in accordance with the currently approved protocol, SOPs, GCP/ICH Guidelines and other applicable regulatory requirements. Job Responsibilities
- Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out according to sponsor SOP's.
- Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan.
- Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
- Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues.
- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
- Experience working on Oncology trials or complex studies would be an advantage for this role.
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