Senior Clinical Research Associate
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.
- 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.
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