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Job Details

Senior Clinical Research Associate

Company: Covance
Location: Zollikon
Reference: 2017-14468
Closing Date: 25 Nov 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

We are currently recruiting for a Senior Clinical Research Associate in Switzerland for our Flexible Solutions team. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Switzerland. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.

Requirements:

Duty Highlights:

Act a primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies.

Communications with sites on issues related to protocol conduct, enrolment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments.

Perform on site- monitoring visits, esuring site compliance with protocol, ICH, GCP, Merck global standards, local laws and regulations, including but not limited to review of informed consent, AE/SARs, Health Authority documention, and IMP supplies.

Perform source document verification of subject data and query resolutions.

Functional expert on the CRA role and would be expected to role model and mentor junior level CRAs. Share best practises and make recommendations for continuous quality improvement. Actively participate in change management processes.

Represent the department on cross functional/interdepartmental teams and take on extra assignments as they arise.

Manage at least a full complement of sites with multiple protocols depending on study/site complexity.

Provide input to Site Selection utilizing site evaluation and validation processes.

Maintains accurate study site information in the CTMS and records visit and non-visits contracts appropriately and in a timely manner.

Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.

USPs of CRA role:

Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets

Join a stable team of CRAs across Switzerland and benefit from outstanding training and development, both initially and throughout your career

Join a company where people tend to stay for 6-10 years rather than 1-3!

Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.

Minimum Required:

Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

Excellent understanding of Serious Adverse Event reporting

Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Switzerland

Fluency in speaking and writing German/French/Italian and English

Oncology experience

In lieu of the above requirements, candidates with supervisory experience in a health care setting and clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered

Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Advanced site monitoring skills

Advanced study site management skills

Advanced registry administration skills

Ability to work with minimal supervision

Good planning and organization skills

Good computer skills with good working knowledge of a range of computer packages

Advanced verbal and written communication skills

Ability to train and supervise junior staff

Ability to resolve project-related problems and prioritizes workload for self and team

Ability to work within a project team

Works efficiently and effectively in a matrix environment

Degree in life sciences OR equivalent experience in clinical monitoring

Other Information:These roles are full time & permanent positions employed through Covance.

Apply for this job: Senior Clinical Research Associate

Contact Information:

Address:  Head Office
Maidenhead Office Park, Westacott Way, Littlewick Green, Maidenhead
SL6 3QH
England
Website:  Visit Our Web Site

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