Proclinical Staffing

Senior Clinical Research Associate

4 days left

Location
Munich, Bayern, Germany
Salary
Negotiable
Posted
28 Apr 2021
Closes
12 May 2021
Ref
37193
Contact
Polina Sidorova
Hours
Full Time
Contract Type
Permanent
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.

Skills and Requirements

  • 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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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