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Clinical Research Associate (Rif. CRA)

Data: 20/02/2013

Menarini ricerca: Clinical Research Associate (Rif. CRA)


Area: Clinical Research Line: R&D Clinical Research Department: Job Centre: Menarini Ricerche - Firenze

PROFILE

Education:
Degree in Biology, CTF Language: Fluent in English Previous Experience: At least 2 year experience as CRA/Project Manager in:
• R&D Pharma Company
• Clinical Research Organisation


GENERAL DUTIES & RESPONSABILITIES

It is the general responsibility of the CRA all operational activities relative to the implementation and follow-up of the clinical trials under his/her responsibility from the beginning to the end, in accordance with the guidelines internationally accepted on good clinical practice (GCP), the internal company SOPs and regulations in force. Specific responsibilities of the CRA are:
• Knowledge and implementation of the relevant Company SOPs for the fulfilment of each clinical trial in order to guarantee the quality of data and the completion of activities according to the established timelines.
• Knowledge and adherence to the applicable regulations in force, as well as the internationally accepted recommendations (ICH guidelines) in the field of the clinical trials in order to assure the ethic conduct and quality of the study data.
• Close interaction with CRO for study activities which are contracted out.
• Exhaustive follow-up (monitoring) of the experimental phase of the clinical trials assigned, supervising the investigators job and checking the fulfilment of the GCP.
• In depth knowledge of the characteristics of the investigational drugs in the study (Investigator Brochure) and the protocols of each clinical trial assigned to correctly carry out the monitoring work.
• Adequate knowledge of the guidelines pertinent to the therapeutic area relevant to the assigned study and to Pharmacovigilance requirements.


MAIN ACTIVITIES AND TASKS

• Preparation of all the documentation required to start a clinical trial (communication to the Ethic Committee, Health Authorities etc.).
• Properly maintain the Trial Master File to be audited at any time.
• Collaborate with the Medical Monitor in the elaboration of the protocol and in the design of the Case Report Form (CRF).
• Collaborate with the Medical Monitor in the selection of investigators.
• Prepare the documentation and material needed for the start-up visits of the clinical trial.
• Collaborate in the organisation of the investigator meetings and collaborate as speaker in such meetings.
• Organise and carry out the monitoring visits: source data verifications from the clinical records of the subjects included. Help the investigators to correctly fill in the CRFs and implement the procedures of the protocol.
• Prepare the relevant monitoring reports.
• Ensure and guarantee the quality of data that the investigator collects.
• Prepare the final visits of clinical trial
• Detect any problems during of the performance of the clinical trial (protocol deviations, delayed timelines, suspicion of fraud, etc.) and propose solutions.
• Closely interact and supervise CRO’s performance when study activities are contracted out.
• Complete check of the CRF consisistency, including Pharmacovigilance data.
• Perform one of the two processes for the double data entry of clinical trials under his/her responsibility.
• Overview/manage the operativities relative to study treatment/rescue medication and clinical samples at the site (shipment to site, storage, drug accountability, drug destruction etc).
• Collaborate with the Medical Monitor in the elaboration of the final report.
• Elaborate the entrusted SOPs related to Clinical Trials.
• Be updated on the most relevant guidelines pertinent to therapeutic area of the assigned studies as well as with legislation related to clinical trials.

We especially appreciate receiving résumés from the disability protected class, as defined by Law 68/99, which meet the requisites illustrated above.


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