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Job Details

Senior CRA

Company: SRG Clinical
Location: Edinburgh
Reference: J25378
Closing Date: 09 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits: pension, negotiable

Job Summary:

Clinical Research Associate and Senior Clinical Research Associate - Medical DevicesPermanent opportunity Office-based in Scotland Sites across the Scotland and UK

Requirements:

2 permanent positions for senior CRA and CRA with a dynamic diagnostics company developing breakthrough medical devices.

You will be responsible for conducting all clinical studies to support product development, regulatory submissions and post-market evaluation for In Vitro Diagnostic products. Studies will range from single site to international multi-centre so some travel will be required.

Major Responsibilities:

* Implement clinical trial study design as per the product launch plan.
* In conjunction with the Clinical Manager identify appropriate clinical sites and manage effective clinical relationships.
* Attend investigator meetings as required.
* Prepare, edit, review and submit clinical documentation according to study needs including but not limited to:

* Ethics Submissions
* R&D Applications
* Protocols & Protocol Amendments
* CRFs
* Patient Information Sheets
* Consent Forms
* Training Materials

* Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required e.g. IRAS, HRA, R&D.
* Implement, conduct, monitor and report clinical studies according to all business processes.
* Monitor clinical trials to ensure compliance to the study protocol, clinical business processes, applicable regulations and the principles of ICH-GCP, typically 50% of active sites.
* Perform pre-study initiation, interim monitoring and close out visits as required.

Requirements:

* A Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or equivalent experience or a minimum of one years’ 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 perform pre-study initiation, interim monitoring and close out visits as required.
* Excellent communication skills, including the ability to present complex information to both clinical and non-clinical disciplines.
* Willingness and ability to travel.
* Driving licence.

About SRG:

SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of ‘Creating Tomorrow’s World’& helping patients world-wide.

HOW TO APPLY?

For an immediate consideration please press 'apply' now, alternatively contact Gary Montgomery on 07789 878 300 or and get more information about the role.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Apply for this job: Senior CRA

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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