CLINICAL DEVELOPMENT SERVICES AGENCY An extra mural unit of THSTI, An autonomous organization of Department of Biotechnology Ministry of Science & Technology, Govt. of India 3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway, Faridabad – 121001 (Haryana) Recruitment Notice No. CDS/RN/13/2019 Name of the Program & post Emoluments Duration Location Job profile
“ NBM Program” Clinical Research Associate – 01 Position Upto Rs. 55,000/- per month consolidated One year CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad
He/ She will plan and conduct clinical monitoring activities for the clinical trials/ studies that are assigned to CDSA through the consultancy grant from NBM. CRA will ensure that the studies are conducted in accordance with study protocol, standard operating procedures, good clinical practices, and applicable guidelines He/she will perform site monitoring activities during assigned study start-up, initiation, conduct and closeout, in accordance with contracted scope of work Perform site monitoring throughout the trial which involves visiting the trial sites on a regular basis (site initiation to site closeout) in accordance with contracted scope of work Perform quality functions and execute quality programs (clinical operations, clinical laboratory) as per GCP and regulations Complete appropriate therapeutic, protocol and clinical research training to perform job duties. Ensure setting up the assigned trial sites as per protocol and applicable requirements. Ensure protocol and related trial training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Support NBM-PMU for appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required trial documentation. Manage the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution. Verify that data entered on to the CRFs is consistent with