Siddharth Kamble

About Siddharth Kamble

I am Siddharth Kamble, a dedicated Clinical Research Associate with three years of…

Experience

1. Clinical Research Associate

   Advity Research

   Apr 2025 — Present · Hyderabad, IN

   Preparation of feasibilities for clinical trial proposals received from BD/PM personnel. •Obtaining acceptance for trial feasibilities from potential sites/investigators and identity the suitability of facility at sites.•Perform monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with Advity procedures and regulatory requirements, Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.•Actively participate in study team and investigator meetings.•Assisting to sites for submission of Protocols and other study documents to IRB/IEC.•Train and guide site staff in trial protocols and related study training to assigned sites and regular communication with sites to manage ongoing project expectations and issues.•Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.•Review study subjects safety information and ICF and conduct source document verification for compliance, patient safety, and veracity of data.•Responsible to IP supplies, accountability and retention quantity at study center.•Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment case report form (CRF) completion and submission.•Coordinate with the sites for SAE reporting in time to sponsor, CDSCO, and local regulatory authorities.•Ensure copies/original (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigators Site File (ISF) is maintained GCP and local regulatory requirements.•Closing down study centers on completion of the trial.•Archiving study documentations and correspondence.

Education

• Sant Gajanan Maharaj College of Pharmacy, Chinchewadi, Mahagaon,

  Diploma in pharmacy

  2015 — 2017

• Dr.Babasaheb Ambedkar Technological University, Lonere - Raigad

  Bachelor of Pharmacy - BPharm

  2018 — 2021