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Job Description and Requirements
Duties and Responsibilities of the CRA/Monitor:
•To verify that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s)
•To verify that the rights and well-being of human subjects, clinical study’s participants, are protected
•To verify that the investigator has adequate qualifications and resources, as well as that, facilities, including laboratories, equipment and staff are adequate for safely and properly conduct of the clinical study throughout the study period
•To act as the main line of communication with Investigator and his team
•To verify that the reported study data are accurate, complete and verifiable from source documents
•To verify Investigational medicinal product and other study materials tracking
•· To report status of the projects to relevant Project Manager
•Undertaking other study specific activities described in study/project operational plans/documents or timetables in line of his/her education and qualifications
•To act as a mentor to the less experienced staff such as Clinical Trial Administrators and CRA/Monitors
•· To participate in the process of revision of relevant Standard Operating Procedures (SOPs)
•To perform presentations and training to the more junior staff (CTAs, CRA/Monitors) in line with their experience and as assessed by the Quality Management
•BS/Pharm.D/MSc/MD or RN, with 3 years of on-site clinical monitoring experience. .
•Strong customer focus, ability to interact professionally within a client organization
•Ability to prioritize multiple tasks and achieve project timelines
•Sense of urgency in completing assigned tasks
•Attention to detail
•Excellent verbal and written communication skills.
•Must be computer literate and proficient in MS office.
•Ability to perform country-wide and regional travel an average of 65%, depending on project needs.