• Serving as Co Investigator and responsible for overall conduct of assigned BA/BE studies of Alkem Labs Ltd., India.
• Review and signing off on BA/BE study protocols, ICFs and Bioequivalence reports.
• Imparting training to clinical staff on study protocols and delegate them appropriate roles in study as per qualification, experience and training.
• ICF presentation to volunteers during screening and before study resolving queries of the volunteers and obtaining Informed consent from them.
• Review of ECG, X-ray and Clinical pathological reports of volunteers/ subjects.
• Counseling and handling of HIV and Hepatitis B positive volunteers.
• Supervision and/or administration of Investigational Drug product to subjects.
• Data entry in the CRFs and ensuring the accuracy, completeness, legibility and timeliness of CRFs.
• Medical management and reporting of adverse event (AE) and serious adverse event (SAE).
• Reporting and handling any protocol deviation, early termination and withdrawal of subjects from the study.
• Handling medical emergencies during the conduct of BA/BE studies.
• Review of subject CRF’s and other study documents compiled in Trial Master File (TMF).
• Review of Clinical study report (CSR).
• Determining volunteer fitness and eligibility for participation in studies.
• Maintenance, review and updating of Volunteer Data Bank.
• Review and updating Standard Operating Procedures (SOPs) of medical concern in the clinical section.
• Interaction with IEC, Clinical pathological laboratory, Bioanalytical section, QA section and statistical section
• Preparation for Inspection and Audits.
Hoping your positive Response.
If you are interested for this opening just revert me with your updated resume, Expected and Current CTC, or else you can contact me on below phone number., & If you are not interested then forward this to any of your friends or colleagues.
Also inform your availability of time and alternative number so as per your availability I will contact you 8141911666. email id firstname.lastname@example.org
Awaiting your positive Response.
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