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| Job Location | Delhi |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | NGO / Social Work |
| Functional Area | Sales / BDCustomer Service (International) |
| EmploymentType | Full-time |
Description:
1.Preparation of Feasibility Study reply with the help of PI and study lead. 2.Preparation of Investigator database 3.Ethics Committee package preparation and submission, help in replying queries by EC. 4.Assist in Screening including informed consent process, randomization, enrolment follow-up (including Telephonic Follow-up) process procedures. 5.Maintenance of Investigator Master File as per Good documentation practices SOP including generation of source documents. 6.Present in Site Initiation Visit, Monitoring Visits, Site Closeout Visit. 7.CTA negotiation Coordination with the legal team for legal implication on the CTA. 8.Coordination with the central team for budget optimization 9.Maintancae of monthly finance tracker 10.Track different invoices as per study milestone achievement 11.CRF, e-CRF entry, Data Query resolution. 12. Help in Protocol specific sample collection shipment of Lab samples and IP. 12.Other Miscellaneous activities like documentation, record keeping, IP Accountability etc. 13.Safety reporting of Clinical research participants and compile submit CIOMS and Appendix XI. 14.Ensuring documenting and following the process as per NABH standards
Education: Nursing, B.Pharm, M.Pharm, PhD MBBS, MD, MS, DNB, DM BDS, MDS, BAMS, BHMS, BUMS BPT, MPT, B.Tech, B.sc, M.sc, PhD Biotechnology / Microbiology/ Biochemistry /Zoology/ Anatomy/Physiology/ Bioinformatics/ Health Education/Lab Technician/ Chemistry/ Biomedical etc. Working Professionals
,Keyskills :
pharmacovigilancecase processing casedata entry safetyhuman resource management life sciencesrecord keeping