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| Job Location | Delhi |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Statistics / Analytics |
| EmploymentType | Full-time |
Sr Research Officer Job detailsJob Details Sr Research Officer Description : i. Efficient management of clinical operations at the study site; ii. Providing input into study related materials such as clinical operations plan, SOPS, CRF completion guidelines, training module, informed consent, site instructions for specimen collections, study logs/ forms and other study related documents; iii. Assisting the Clinical Research Coordinator (CRC) and site investigators for the site preparation; iv. Supervising the study nurses and the clinical technicians posted at the hospital site: including their attendance, punctuality, completion of tasks/ activities assigned to them, training; v. Supervision of process of taking written informed consent ; vi. Supervision of ensuring eligibility of infants before they are enrolled in study; vii. Supervision of outcome assessment viii. Final review of the CRF and the signing of the CRF (as a part of QC); ix. Tracking the reports of all the laboratory samples collected for standard clinical care for clinical severe infection ; x. Tracking the collection, immediate processing, temporary storage and transportation of bio specimens collected for the research study; xi. Supervising flow of clinical and lab data from point of collection to data management centre; xii. Reviewing participant recruitment, protocol deviations, loss to follow up for hospital site performance; xiii. Providing input and support to maintain appropriate documentation for adverse event safety monitoring; xiv. Liasoning with the QM team to ensure good quality of study data ; xv. Providing support to CRC and site investigators to prepare for clinical audits and to respond to audit findings conducted by internal QA and external agencies; xvi. Liasoning with QM and DM team and timely resolution of queries in data collected; xvii. Keeping site investigators informed on study progress, risks and accomplishments. No of Vacency :,
Keyskills :
researchdata managementsafety monitoringsite preparationexternal agencies