Clinical Research Associate (CRA)

At Omega CRO, we are looking for an experienced Clinical Research Associate (CRA) to take on the monitor and monitoring responsibilities defined in section 8 of the Good Clinical Practice Guideline (01.02.2024).

You will visit research sites before, during and after the clinical research; verify that the principal investigator and investigators have appropriate qualifications and resources, and that the staff and facilities (including laboratory and equipment) are safe and adequate to conduct the research. Depending on the nature and risks of the research, you will also apply remote monitoring approaches.

During monitoring visits, you will verify case report form (CRF) data against source records; ensure dose changes, adverse events, concomitant medications and missed visits or tests are reported per protocol; confirm informed consent forms are complete and that investigational products are stored correctly, dispensed to eligible volunteers at protocol-specified doses and durations, and documented on receipt, use and return.

You will also act as the communication channel between the sponsor and investigators, follow up safety reporting to the Turkish Medicines and Medical Devices Agency, the ethics committee and the sponsor, report protocol and GCP deviations to the principal investigator with corrective steps, and submit written monitoring reports after every visit, covering your observations, findings and actions taken.

• Bachelor's degree in Pharmacy, Medicine, Dentistry or health/science disciplines
• Minimum 2 years of CRA/monitor experience, including on-site monitoring visits
• Basic Good Clinical Practice (GCP) training — mandatory under the guideline
• Comprehensive knowledge of investigational products, study protocols, informed consent forms, sponsor SOPs and applicable regulations
• Source data verification (SDV) and report writing skills
• Good written and spoken English
• Valid driver's license and availability for regular travel between research sites