Clinical Monitor in Surrey

40,000 - 60,000
04 Jan 2019
01 Feb 2019
Contract Type
Brandon Whates is recruiting for a Clinical Research Associate to join a company in the biopharmaceutical industry at their site based in Surrey on a permanent basis. 

The main purpose of the role will be to:
- Manage the conduct of clinical trials in accordance with the protocol, ICH GCP guidelines, applicable local and international regulations and company SOPs to ensure the timely delivery of clinical trial reports within budget.
- Liaise with internal and external experts regarding proposed protocol scope, budget and timelines.
- Identify, assess and select appropriate investigators/sites and other service providers according to project requirements and company SOPs.
- Manage preparation and execution of site initiation and associated meetings.
- Ensure all study materials including investigational medicinal products are procured appropriately and available on site when required.
- Ensure all labeling requirements are met.
- Assist in securing import documentation if necessary.
- Arrange adequate storage and dispatch of investigational medicinal product and study materials to the investigational site.
- Collect and compile essential documents (according to ICH GCP guidelines and company SOPs).
- Prepare required HREC/IEC applications in a timely manner.
- Train study staff in all study related processes / procedures.
- Coordinate meetings with investigator and study site staff.
- Monitor the progress of clinical trials through regular visits and correspondence to ensure satisfactory conduct of trials including: monitor recruitment and consenting procedures, adherence to the study protocol, completion of CRFs and review of source data, collection of data as specified in project plans, review site files and accountability logs &ensure reporting of visit occurs in a timely manner and according to company SOPs.
- Report adverse events in compliance with regulatory requirements and company SOPs.
- Ensure all data queries are resolved.
- Ensure all essential documents are complete and filed appropriately.
- Ensue accountability and reconciliation of study materials and investigational medicinal product.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Graduate qualifications in Biological Sciences, Nursing.
- Pharmacy or related discipline.
- Post-graduate qualifications desirable.
- Proven monitoring experience in a CRA role.
- Working knowledge of ICH GCP guidelines.
- Management of clinical trials/projects in Europe.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL44298 in all correspondence.

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