A- Job Specification:
|Quality Manual:||Human Resources Manual|
|Job description Reference:||JD –Jr CRA|
|Title:||Clinical Research Associate – Country|
|Based in:||City – Country|
|Job Type||Full or Part Time|
|Purpose:||A Clinical Research Associate (CRA) has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement.|
|Report to:||Clinical Research Manager – KSA.|
|Job Qualification:||· Bio-medical related scientific degree.
· Strong interest in clinical research.
· Professional use of the English language; both written and oral
· Should have ICH-GCP training internally.
B- Key Functions:
- Act as the main line of communication between the sponsor and the investigator
- Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout
- Responsible for the safety and proper conduct throughout the trial
- Verifying that the investigator follows the approved protocol and all GCP procedures
- Verifying that source data/documents and other trial records are accurate, complete, and maintained
- Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs
- Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator
Please submit your C.V at CV@nagyresearch.com