Venkatakrishna Rao Amara

About Venkatakrishna Rao Amara

Objective A challenging position as a Clinical research associate (monitor) in…

Experience

1. Manager

   MSN Laboratories

   Apr 2022 — Present · IN

   Involved in Bioavailability and Bioequivalence studies.• To prepare the protocol synopsis and send it to CROs for preparation of Final Protocol.• Review of protocols, CRFs and supplemental study documentation for its approval and Execution.• Literature collection for investigational products.• Organize and supply of investigational products to CROs. • Coordinating with the internal Regulatory team for obtaining the B.E NOC, T-License and Import License.• Communication with the CRO about the status of the study.• Monitoring of the clinical studies according to approved protocol, SOP’s, ICH/GCP and applicable regulatory guidelines (USFDA, EMEA, WHO, Turkey….etc). To verify the protection of the Right, Safety and Well-being of the subject. To verify the pre-study activities and screening records To verify the written informed consent forms was obtained before participation of the subjects in the study. To verify the completeness and accuracy of all the entry of CRF. To verify the deviations of blood samples and the vitals and documentation of the same. Accountability, handling and storage of investigational products. To verify the all study documents• Review of Clinical Study Reports.• Verification of source data, investigational product(s) accountability and serious adverse events review.• Handling of regulatory queries or deficiencies (Related to Biostudy) and preparing a response.• Conduct frequent team meetings to ensure regular communication. • Preparation of statistical report.• Response to ROW queries and support to regulatory department.• Creation of Individual plasma concentrations verses time profile graphs, mean graph, Calculation of descriptive statistics and Non Linear pharmacokinetic and pharmacodynamic analysis were done by using WinNonlin system.• Calculation of descriptive statistics like Arithmetic mean, standard deviation, coefficient of variation; median, minimum and maximum and Geometric mean.

Education

• Indian Institute of Management, Indore

  Certicate programme in Project Management

  2024 — 2025

• Osmania University

  Diploma

  2000 — 2001

• Rajiv Gandhi University of Health Sciences

  B.Pharma

  2002 — 2005

• Periyar University

  Master's Degree

  2012 — 2014

• State

  S.S.C; of

  1994 — 1996