Clinical Field Officer

At Omega CRO, we are looking for a Site Field Officer (Saha Görevlisi) to deliver site organization management services at the research site, under the supervision and oversight of the coordinator or principal investigator, within the scope of the Turkish Medicines and Medical Devices Agency guideline on Site Organization Management in Clinical Research (13.11.2015).

Supporting the clinical research team, you will help pre-screen volunteers who meet the study criteria, ensure informed consent forms are filed, organize and track volunteer visit appointments, manage shipment of blood samples to the laboratory per protocol, support complete recording into hospital source documents and assist data entry into case report forms (e-CRF) without any modification.

You will also facilitate timely reporting of safety notifications by the principal investigator to the sponsor, track submissions to the ethics committee and the Turkish Medicines and Medical Devices Agency (protocol amendments, investigator notifications), monitor the availability of study materials and support the archiving of study files.

The site field officer is authorized internally by our CRO, does not work simultaneously on studies with different sponsors, and supports at most five principal investigators. The work is also monitored through semi-annual monitoring reports submitted to the Agency.

• Graduate of health or science faculties (preferred)
• Basic Good Clinical Practice (GCP) training — mandatory under the guideline
• Willingness to take study-specific training for the assigned clinical research
• Meticulous source document and file management with disciplined archiving
• Strong organization, scheduling and follow-up skills
• Good written English
• Valid driver's license and availability for regular travel between research sites