Clinical Research Associate

Proclinical has an opportunity for a Clinical Research Associate to join an expanding global company in Switzerland for a Permanent, home based opportunity.

The Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Job Responsibilities:

• Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
• Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
• Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
• Assist with study protocol design, development and / or review if required
• Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
• Perform pre-study initiation, interim monitoring and close out visits as required
• Carry out drug formulation administration procedures and documentation records
• Ensure adequacy of drug shipment and drug accountability
• Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
• Organise / attend investigator meetings as required
• Provide support to the Project Manager / Country Manager with ad-hoc tasks as required

Skills and Requirements:

• Bachelor's degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
• Clear understanding of the drug development process
• Significant experience in performing a Clinical Research Associate role
• Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company
• Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
• Ability to contribute to the development of clinical trial related documents and materials
• Ability to independently perform pre-study initiation, interim monitoring and close out visits as required
• Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
• Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail
• Fluency in English and German (both written and spoken) with the addition of French or Italian advantageous
• Willingness and ability to travel
• Willingness and ability to be Home based in Country
• Experience across a wide range of clinical indications / therapeutic areas
• Ability and experience to work with an electronic case report form (eCRF)
• Membership of local professional bodies or international clinical groups
• Ability to mentor, train, supervise and inspire confidence in newcomers to the industry

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 Sasha Brasero on +44(0) 203 854 0535 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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