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Clinical Research/pharmacovigilance/medical Writing Jobs

Keywords / Skills : molecular biology, biotechnology, microbiology, clinical data management, nursing, pharmacovigilance, biomedical, clinical research, biochemistry, pharmacy, zoology, biotech

Posted: 2019-08-12

Job Description
Job Description:

    Responsibilities:

    Facilitate Pre-study, Site qualification and feasibility, Study initiation
    Co-ordinates all required activities between Sponsor / CRO/ Investigator / EC
    EC submissions, review and approvals
    Co-ordinates Protocol related research procedures, study visits, and follow-up care Screen, recruit and enroll patients/research participants
    Collect, process and ship laboratory specimens Schedule subject visits and procedures
    GCP compliant study conduction and documentation
    Manage all logistics and co-ordinate with internal or external stakeholders
    Facilitate sponsor/CRO visits at sites, monitoring visits, audits and inspections
    Safety reporting: SAE and Adverse event monitoring, documentation and regulatory compliance
    Training and supervision of trial team at site
    Facilitate study close out activities
    Coordinate research/project team meetings
    Retain records/archive documents after study close out

    Skills:

    Basic competence with medical and therapeutic terminology
    Understanding of Patient Safety regulatory obligation
    Good attention to detail
    Ability to deliver within established timelines
    Fluency in Spoken and written English and excellent comprehension

    Details
    Kavana
    9880650498


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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