Senior Clinical Research Associate
- Employer
- Proclinical Staffing
- Location
- Homeworking
- Salary
- Negotiable
- Start date
- 14 Jan 2021
- Closing date
- 28 Jan 2021
View more
- Discipline
- Clinical Research, Clinical Research Associate
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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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Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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