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Senior Clinical Research Associate in Biotech
* To contribute to the development of clinical trial related documents including but not limited to protocols, case report forms, informed consents, conventions, data query plans etc, with the responsible Clinical Monitoring Leader and Clinical Trial Leader.
* To identify/confirm, on request from Clinical Monitoring Management, suitably qualified trial sites within a specified geographical area. To make initial contacts, conduct evaluation visits and subsequently to establish relationships with selected trial sites in order to ensure study targets for recruitment, quality and costs are implemented.
* To assist in obtaining regulatory and ethics approvals, when requested.
* To monitor all stages, from evaluation to close-out, of the conduct of clinical trials at assigned trial sites, write reports within the timeframe agreed at study start, maintain required documentation in the investigator file and provide required documentation for the Trial Master File. To ensure the trial site complies with the study protocol, GCP and applicable regulatory requirements.
* To control the integrity of the data produced by trial sites through review of case report forms, source documents/medical and pharmacy records. To ensure the above is conducted in accordance with the agreed study timelines, with tracking logs effectively maintained.
* To liaise with the relevant drug safety department and the Medical Responsible in the management of serious adverse events and SAEs, and assure appropriate action is taken at the trial site in accordance with the appropriate Policies, Standard Operating Procedures (SOP), Work Instructions and conventions, as well as current Good Clinical Practice (GCP) and applicable local regulations.
* To provide trial site updates to the CM Leader, Clinical Trial Leader and Medical Responsible within the timeframe agreed for the study and in accordance with the nature of the communication (critical versus routine).
* To assist in negotiating grants and contracts, and in budget forecasting and payments.
* To manage investigational medicinal product supplies at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates, and assist in investigational medicinal product forecasting in accordance with study agreements.
* To assist in the preparation for trial site audits and inspections, and to participate in the audits and inspections and in responding to any issues identified within the timeframe specified.
* To maintain/develop a good level of scientific knowledge within Sponsors therapeutic areas.
* To maintain and develop PC skills required to work efficiently.
* To liaise with other CRAs to ensure harmony of standards and procedures and to contribute to the review (and drafting) of existing and new SOPs, Work Instructions and study specific conventions, when requested. Participating in working groups if needed.
* Biological science/pharmacy/nursing degree or Nursing qualification.
* Minimum 5 years CRA experience or combination of CRA + other relevant experience (e.g. regulatory, clinical QA, pharmaceutical sales, study site coordinator).
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