Pavankumar Ade

About Pavankumar Ade

Reviews and develops a familiarity with the protocol, e.g, study proceedings and…

Experience

1. Senior Clinical Research Associate

   Ardent Clinical Research Services

   Aug 2025 — Present · Pune, IN

   Reviews and develops a familiarity with the protocol, e.g, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.Provides appropriate training and tools for study team members. Source Data verification and monitoring the data on EDC tools.Collects documents needed to initiate the study and submit to the sponsor (e.g, FDA Forms 1572, CVs, Investigator Statement, required study documents etc.).Works with the PI and site staff to develop and implement recruitment strategies in accordance with Sponsor requirements and approvals.Review of screened subject’s data for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.Responsible for site qualification, site initiation, Interim monitoring visits, site closeout visits, drug accountability, remote monitoring visits post completion of the visits responsible to submit the monitoring reports to reviewer and sponsor.Review of ISF/SMF and Site related documents.Guiding site staff on PD filing and training the site team as and when required.Validation of ICF/IAF and Facilities.Assure to maintain study timelines.Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol.Completes study documentation and maintains study files in accordance with sponsor requirements and organization policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.Maintaining TMF/eTMF documentation (as required)

Education

• master of pharmacy BAMU university Aurangabad

  master of pharmacy from BAMU university Aurangabad, Pharmacy

  2016 — 2018

• B pharmacy RTMNU university

  DBCOP RTMNU Nagpur university, Pharmacy

  2012 — 2016