Major Responsibilities:o Study protocols reviews o Coordination with Investigators, Sponsors, CROs and IRB.o Organizing meetings prior to Study initiation and during the Study.o Submission and follow-up of regulatory documents  IRB Application, renewal, progress and close out reports  Grants and other regulatory applications for approvals  Study agreements (Clinical trial agreement, confidentiality agreement, MOUs etc.) Safety reporting to the sponsors, ERC, Pharmacy and institutional online system o Study team training related to research protocol, GCP, and other regulatory guidelines o Prepare Study budget and get approval from sponsor, human resource and finance department.o Study set-up (booking and scheduling) o Administer Informed Consent to the study subjects o Data collection, data entry on CRFs/eCRF and query resolution o Facilitate monitoring and audits (sponsors, IRB, DRAP, JCIA etc.)o Study site close-out processes.o Facilitate orders for equipment required to conduct researches. o Draft SOPs, Manuals and templates and get approval from the director and other institutional stakeholderso Conduct interviews with the director for hiring new staff i.e., research assistants, research pharmacists and data collectors

proven record of managing 50+ clinical trials from startup to close out

Track record of managing 50+ phase II to Phase IV Clinical Trials from start to closure

Joint Faculty

overall operations management of clinical trials