Clinical Research Executive
Russell Oakley is currently recruiting for a Clinical Research Executive or Clinical Trials Coordinator to join our client at their site based in Cambridgeshire on a permanent basis.
The main purpose of the role will be:
To support the Clinical Operations and Pharmacovigilance Group. They are expected to offer specific technical expertise and may be considered the in-house lead for a relevant activity (such as medical writing or legal representative responsibilities) and may also be required to provide more general support to the Clinical Team. In addition, they work with other GFA staff to develop and promote the business, maintaining an awareness of, and providing feedback on, client, industry and regulatory development to input into the strategic development of the company.
Duties include, but are not limited to:
Review / preparation of draft study documents including: clinical study protocols, Investigator Brochures, Case Report Forms, Patient/subject informed consent forms, Ethics Committee submissions for clinical studies; Review / preparation of draft clinical study reports; Review / preparation of periodic project progress reports for clients; Review / preparation of Standard Operating Procedures; Identification of clinical investigators; Management of the Trial Master File for clinical studies as per GCP; Management of the creation and maintenance of study-specific forms; Management of the collation and copying of documents for Ethics Committee submissions; Management of the archiving of study documents at the close of a project; Organisation and planning of study-related meetings; Handling of telephone and other enquiries from study site staff and clients during a study, as appropriate;Processing and reporting of adverse events, as appropriate;
Desirable qualifications and experience:
Experience of working in a pharmaceutical/healthcare product development environment; An overall understanding of drug development and the Clinical Trial process; Competent IT skills including the use of MS Office applications in Word, Excel, PowerPoint and Outlook.
For more information or to apply for this position, please contact Russell Oakley on 01246 457733 or email firstname.lastname@example.org Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and 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 CL30421 in all correspondence.