Study Clinician: *The study clinician'sresponsibilities will include providing medical expertise, overseeing clinical activities, ensuring participant safety, and collaborating with the research team to achieve study objectives.
Medical Oversight: Clinical assessments and medical guidancethroughout the study.
Review informed consent forms and other study-related documents.
Assess and manage adverse events, protocol deviations, and medical emergencies as they arise during the study.
Participant Management:
-Screen and enroll eligible participants according to study criteria.
-Conduct physical examinations, medical history reviews, and clinical assessments.
-Monitor participant safety and well-being throughout the study period.
Review of all lab results, other tests as per the protocol and also those done as a part of standard of care.
-Address participant questions, concerns, and medical issues as they arise.
Study Coordination:
Collaborate with the research team to perform study procedures and all required evaluations.
Coordinate with study coordinators, nurses, and other staff to ensure smooth study operations.
Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and study protocols.
Data Collection and Analysis:
Collect and document accurate clinical data during participant visits. Resolve all queries of source documents and CRFs.
Training and Education:
Provide training to study staff on study protocols, procedures, and clinical assessments.
Educate participants about the study objectives, procedures, and potential risks.
Stay updated on the protocol, and amendments and accordingly implement those in the clinic.
About BJGMC-JHU-CRS:
BJ Medical college, Pune has collaborated with Johns Hopkins University to form a Clinical Trial Unit and has been conducting clinical trial since 20 years. Aiming for a ground-breaking innovation in patient treatment with each year passing it is the biggest Clinical Research Site with the JHU collaboration in India.
