Nisarg Patel

Experience

• 

  Veeda Clinical Research

  Sept 2013 - Oct 2015

  Research Associate

  • Developing the skills for the Clinical research Associate i.e. Site identification, site initiation, site monitoring and close out visit.• GCP monitoring of Clinical trials (BABE & Clinical Trial) for USFDA, Health Canada, MHRA• Conducting trend analysis, Root cause analysis, CAPA review• Experience of performing process mapping, FMEA (Failure mode effect analysis) and process optimization.

• 

  Lambda Therapeutic Research

  Nov 2015 - Aug 2016

  Sr. Research Associate

  • Monitoring for clinical trials in oncology, Diabetes, Arthritis for different regulatory studies. • Monitored late phase clinical trials and reviewed clinical trial documents i.e. protocol, study specific logs and forms, study specific plans, clinical study report• Reviewed Statistical Analysis plan for late phase trials• Reviewed protocol deviation, CAPA analysis, IP accountability in pharmacy as well as on clinical trial site • Reported monitoring observation and performed compliance verification of audit observation• Reviewed Clinical trials SOP for clinical trial management department. Show less

• 

  Zydus Research Centre

  Aug 2016 - Apr 2018

  Research Associate

  • Monitored late Phase clinical trials including in different therapeutic areas i.e. oncology, Diabetes, Arthritis, NASH & HIV from sponsor’s end.• Responded to regulatory queries and communicated• Reviewed clinical Trial documents i.e. PMP (Project Management Plan), ICF (Inform Consent Form), Deviations spreadsheet, SOPs, monitoring tools for risk-based analysis, TMF (Trail Master File), Data Management forms and trails, SAE (Serious Adverse Events) reporting forms, Clinical study reports, Statistical Analysis Plan.• Presented monitoring aspects in Investigator meetings or Kick off meetings before initiation of clinical trials across all sites.• Tracked and reviewed of study progress, subject recruitment, Subject visit, site deviations, protocol waivers, EDC entry. Show less

• 

  Cliantha Research Limited

  Nov 2018 - Feb 2020

  Clinical Research Associate

  • Responsible for Trial Site (Potential Investigator) identification, site feasibility, initiation, monitoring, close-out, and premature close-out visits• Responsible for training of site study team for the monitoring plan, e-CRF, Source data, recording & maintenance of essential documents and for startup activities, GCP, GDP & site initiation• Responsible for Planning and presentation at investigator meetings• Responsible for Site feasibility, Site Qualification, Site Initiation, Site monitoring, Site closeout visits• Responsible for maintenance of essential documents (e-TMF)• Responsible for IP accountability and availability, tracking and management of all Clinical Trial related supplies shipped to the sites Show less

• 

  ICON plc

  Feb 2020 - Jan 2022

  •Tracking subject enrollment and identify recruitment & retention issues, maintain regular communication with site staff. Documenting and communicating study site progress and issues/concerns to the project team.•Conducting site qualification, initiation, monitoring and close out visits at the trial sites.•Offering resolution strategies, documenting follow-up activities/outcomes for clinical trial issues•Following the Site Management / Ownership / Partnership model to monitor multiple Phase I, II, III and IV clinical trial sites, across therapeutic areas.•Schedule and prioritize workload to meet projected deadlines.•Providing adequate reporting and tracking of AEs, protocol deviations and subject status.•Conduct all work according to client SOPs: Potential Investigator Selection Study Initiation, Monitoring, and Close-out Visits. •Manage and maintain home office, as appropriate, including reference study/site files to support monitoring responsibilities. Show less

  • Clinicla Research Associate II

    Sept 2021 - Jan 2022

  • Clinical Research Associate I

    Feb 2020 - Oct 2021
• 

  PPD

  Jan 2022 - now

  Clinical Trial Manager