Greece Job Openings
Excelya
Clinical Research Associate (CRA)
FULL TIME
November 27, 2024
General Responsibilities/Tasks:
- Monitoring of international clinical trials on phases I to IV.
- Conduct monitoring of clinical studies.
- Ensure the monitoring and scientific, technical and regulatory quality of international studies.
- Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administrated to the subjects / patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately re( labelled), imported and released / returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Contribute to the administrative missions required to set up and monitor clinical studies.
- Carry out monitoring and co-monitoring visits with local CRAs to ensure the quality of the data collected, source documents and archiving of investigative documents.
- Interpret the information collected by the various stakeholders in the study and contribute to the implementation of corrective or preventive actions if necessary.
- Be in contact with the study investigators.
- Revise the study sites if necessary.
- Prepare the sites and contribute to the audits and inspections.
- Write visit reports in English.
- Ensure the traceability of the deviations encountered according to a CAPA procedure.
Minimum Requirements :
- Bachelor’s degree in a life science or any related field.
- Minimum of 1 year of experience in monitoring activities as a CRA within the international clinical trials in the pharmaceutical industry.
- Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory timelines.
- Knowledge of the following systems: E-TMF, E-CRF.
- Excellent communication, presentation and interpersonal skills.
- Fluency in written and oral English essential.
Summary
-
Type of job:
Full-time -
Location:
Greece -
Capability:
Clinical Research
Contact
Athina Bara
International Talent Acquisition Officer
International Talent Acquisition Officer
We regret to inform you that this job opportunity is no longer available as it has expired
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