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Clinical Research/pharmacovigilance/cdm

Keywords / Skills : Clinical Research, pharmacovigilance, cdm, Investigator database, Clinical, CRF, e-CRF entry, Data Query resolution

0 - 5 years
Posted: 2019-07-21

Bio Technology & Life Sciences
Health Care
Clinical Research Associate/Manager
Posted On
21st Jul 2019
Job Ref code
Job Description
Job Description:

    Job 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 :Msc., lifescience,nursing , B.Pharmacy/M.Pharmacy/ PharmD, M.B.B.S, B.D.S, B.H.M.S, B.A.M.S, etc.) and lifescience graduates.

    For details

About Company

Resolve Resolve is a leading global research organization providing comprehensive, integrated drug development, laboratory management services. Our clients and partners include pharmaceutical, biotechnology, medical device, and academic and government organizations. Resolve applies innovative research, therapeutic expertise and a firm commitment to Pharma companies and time curve of drug development and optimize value in delivering life-changing therapies, drugs to improve health.
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