Clinical and Regulation Department
Clinical and RA associate
Primary function of the position
Under the oversight of the CRA manager (CTM) the person ensures compliance of study conduct with ICH/GCP and country regulations, company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Roles and responsibilities
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Supports and/or leads audit/inspection activities as needed
- Following the country strategy defined by CRD and CTM, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities
- Whiling to travel abroad including US for sites oversights
- Fluent in Hebrew and English (verbal and written), Excellent English is mandatory
- Min. 2 years of direct site management (monitoring) / CRA experience in a bio/pharma/CRO
- B.A./B.S. with strong emphasis in science and/or biology