Senior Clinical Research Associate

Highly Competitive
  1. Permanent
  2. CRA Manager
  3. Germany
Berlin, Germany
Posting date: 14 Jan 2021
34997

An exciting Clinical Research Organsation (CRO) is looking for a Senior Clinical Research Associate to join their team working remotely in Germany. This is lifetime opportunity to work for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, this will guarantee that the results you help accomplish in drug development are matched by your own career achievements.

Job Responsibilities

  • Act as liaison between the in-house team, vendors, and multiple clinical sites.
  • Work collaboratively with investigative sites to develop strong, long-term, working relationships.
  • Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
  • Help identify and qualify potential investigators.
  • Perform all type of visits from Pre-Study to Close out.
  • Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
  • Assist with start-up activities, including essential document review and collection as requested.
  • Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
  • Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.

Skills and Requirements

  • Prior and solid experience as a CRA 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, have equivalent experience or be a licensed healthcare professional.
  • Experience in central submissions and hospital submissions as well as experience in contract negotiation.
  • Experience working in oncology clinical trials.

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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