Clinical Research Coordinator
Society For Applied Studies - India
New Delhi Area, India
Done consenting of >250 families with Audio video (3700 study sample) & make them understand about all study trial as per ICH-GCP & Protocol. Enroll subjects by voluntarily decision of parents & depending upon inclusion & exclusion criteriaPlans and coordinates the initiation of research study protocol, and the establishment of operating policies and procedures.Working in coordination with Principal Investigator and study team to conduct trial in accordance with protocol, ICH GCP and regulatory requirement Ability to maintain the records & review them.Maintain and Update site file in accordance with GCP and Sponsors SOP.Assist PI to Managing (timely manner reporting and updating) the adverse events, adverse event of special interest & serious adverse events to CRO, Sponsor and E.C.Facilitate monitoring visit and prepare the required documents for monitoring visit.Collection of proper documents required for the processing and analyzing the cases for the detection of deviations.Plans, implements, and maintains data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data.Recruits, instructs, and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.Ensures the smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for internal research staff and as the principle operational liaison for other research organizations, funding agencies and regulating bodies.QC Activity:Done QC (Quality Check) as per ICH –GCP & Protocol of all Case Report Forms (Consent Forms and Summary of Consent Form, Screening Forms, Clinical Assessment Forms, Immediate Adverse Event forms, Immunization Forms.Done QC of team and their allotted work like follow up to the family by doing home visit and by phone visits, & respective forms filled by them like visits forms.