Location: Lisbon, Portugal
Closing Date: 06 Nov 16
Type: Full Time
Salary (£): On Application
Chiltern is Europe’s largest privately owned Clinical Research Organization, with over 4200 employees and 47 offices throughout Europe, both Eastern and Western, North America and in Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones. The Chiltern Source department currently looking for a SRCRA to work client based at Lisbon.
Working as established in the SOPs (Standard Operating Procedures) when controlling the follow-up of the protocol and ensuring that all data obtained are reliable, correct and all of them are collected and reported.
Collaboration in the carrying out of a feasibility study together with the Clinical Project Leader (CPL).
Identification and selection of potential investigators in collaboration with the Clinical Project Leader.
Participation in the preparation of any clinical trial related document in collaboration with the Clinical Project Leader
Verification that the clinical site has all materials, equipment and personnel necessary to perform the trial, and ensure that the center is able to include the number of patients targeted in the protocol.
Verification that all the study staff at site level have been informed adequately about the protocol, CRFs and study procedures during the study initiation as well as that they’re aware throughout the whole study.
Participation in the preparation of financial agreements along with the CPL.Follow-up of the monitoring visit schedule, as per Monitoring Plan.
Preparation of required documents for monitoring visits: discrepancy resolution form (DRF), data listings (verification), AE follow-up and SAE.
Verification that the information reported in the CRFs is the same that the one in the Patient Record’s and report to the site staff team any mistake/omission.
Verification of the correct and safe storage, dispensation, return and final disposal of the IP supplies, as per local laws.
Elaboration of tools for the investigational team in order to achieve a better performance of the trial.
Collaboration with the CPL performing translations or validations of information regarding the clinical trials.
Collaboration with the rest of the clinical trial team with the organization of Investigator’s Meetings.
Participation in Corporate and external Quality Audits and Inspections.
Collaboration in Pre-Approval Inspection Readiness activities.
Ensures the good management of IP, together with the IP Manager.
At least with 4 years working experience as CRA
• Health care or Health Sciences graduate. Master in Clinical Research or Equivalent Experience
• Experience in performing all visits types: SQV, SIV, SMV, and COV
• Experience across a number of phases and therapeutic areas
• Knowledge of Local Europena and American Regulatory Clincial Practices.
• Knowledge in current local laws.
• High organizational and computer skills.
• Good standard of oral and written English
Centro Empresarial, Euronova, 3 Ronda de Poniente, 0,2Âº, 28760 Tres Cantos, Madrid, Spain
|Tel:||+34 91 187 27 00|
|Fax:||+34 91 187 28 49|
|Website:||Visit Our Web Site|
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