Senior/CRA
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A Senior/CRA job position has opened up at an international contract research organisation providing drug discovery, lifecycle management and laboratory services. With offices in over 45 countries and approximately 13,000 professionals, this company provide innovative ideas behind multiple sectors. This position will be based in Amsterdam.
The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and company SOPs.
Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Responsible for ensuring that data will pass international quality assurance audits. Represents the company in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel.
Will assist project manager or clinical team manager on assigned projects and will take a lead role where required. Will support the line manager to mentor, train and contribute to the development of junior clinical team members. Required to travel 60-80% on average.
Skills and Requirements:
- University degree in a science related field or a certified health care professional or equivalent certification/licensure from an appropriately accredited institution
- Considerable clinical research monitoring experience (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring
- Fluency in English and in the country's native language
- Valid Driver's License where applicable
- In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered
- Expert clinical monitoring skills
- Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures
- Skills to mentor and train other monitors in a positive and effective manner
- Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
- Excellent oral and written communication skills
- Strong customer focus
- Excellent interpersonal skills
- Excellent organizational and time management skills
- Strong attention to detail
- Proven flexibility and adaptability
- Excellent team player with team building skills
- Effective presentation skills
- Ability to work independently as required
- Ability to utilize problem-solving techniques applicable to constantly changing environment
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
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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