Country Clinical Trial Administrator CCTA

A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Country Clinical Trial Administrator to join their Stockley Park team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.

The Country Clinical Trial Administrator is responsible for providing in house support and assistance to assigned Study Teams and management staff. The CCTA will provide support to the Study Team during start up, maintenance and closeout of clinical studies.

Job Responsibilities:

• Support the production, coordination, completeness and accuracy of HRA/EC/NIHR documents and submissions in order to guarantee company studies are submitted and approved in a timely fashion (for early development studies monitored in house)
• Support/Perform Research Contract negotiations with Hospital/Institution, Central Contracts & Outsourcing Group, and the company's Legal Group, to ensure local Start Up timelines are adhered to.
• Customise documents to local requirements as applicable
• Prepare and send Investigator Site Files ready for Site Initiation
• Serve as an additional point of contact for investigative sites.
• Keep the company's Tracking databases up to date and enter study information into National Clinical Trial Database where appropriate.
• Manage local study material and study supplies, as applicable.
• Track Site payments to ensure timely payments are reflective of the contracts schedule.
• Support Clinical Team (e.g. office or home based, and the contract CRAs) in administrative tasks
• Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute communications and study documents to study teams
• File and maintain the study administrative files locally and upload documents into the eTMF
• Design and maintain administrative tracking tools
• May conduct data query resolution and SAE information collection via facsimile, email and telephone
• Participate in and contribute to Clinical Research meetings, study related meetings, training activities and cross functional activities as appropriate
• Liaise closely with the CRAs, Study Managers team and CTAs. 16. Support with TMF and ISF QCs (Travel may be required for QCs but this will be minimal)

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 Andrea Rotmistrovsky on +44 203 854 0675 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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