Knowledge and experience of Site Selection Visits, Site Initiation Visits, Site Monitoring Visit and Site Close Out Visit.
Complete feasibility in different therapeutic areas with Investigators.
Coordinate all aspects of Clinical research study with the study participants, assisting in the development & implementation of research studies, including protocol development, participant recruitment and data collection.
Collaborate with the Principal Investigator to prepare and maintain the IRB documents and other Regulatory submissions and approvals, ensure compliance with regulatory requirements.
Conduct regular study visits and collect data from the study participants in compliance with the study protocol, ICH-GCP guidelines to protect the rights and welfare of human subjects.
Monitoring and documenting the progress of the study participants while they are on study.
Prepare and maintain case report forms (CRFs), enrolment logs and other study documentation, including informed consent document and drug/device accountability logs.
Assist Investigator at the event of SAE for reporting to various stake holders.
Participate enthusiastically in all kinds trainings undertaken by Medical Research Dept.
Provide oversight of lab, specimen processing.
Collaborating with researchers, sponsors and other stakeholders to ensure study success.
Participant recruitment and Retention: Identifying, recruiting, and retaining study participants, ensuring informed consent and participant safety.
Maintain clinical trial documents and site master files.
Handle EC and sponsor communication.

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