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We are looking for a 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, companys 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