Gurpreet Bambra

Principal Clinical Research Consultant at DocQc
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Contact Information
us****@****om
(386) 825-5501
Location
Canada, CA
Languages
  • English -
  • Hindi -
  • Punjabi -
  • Swahili -
  • French Professional working proficiency
Skills

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Credentials

  • Certified Clinical Research Associate (CCRA)
    ACRP Canada
    Apr, 2017
    - Oct, 2024

Experience

  • DocQc
    • Canada
    • Research Services
    • 1 - 100 Employee
    • Principal Clinical Research Consultant
      • Jan 2019 - Present

      DocQc is a Clinical Trial Consultancy that supports clinical research through the provision of trial monitoring, site management & GCP auditing services for both medical device and pharmaceutical studies: pre- to post-market. We support both Sites and Sponsors in all aspects of planning and conducting clinical trials in accordance with federal and local regulations.

    • Clinical Research Consultant
      • Dec 2014 - Jan 2019

      Travel capacity: 40-60%Assess site qualification potential: review study requirements & conduct pre-study visits as well as draft pre-study evaluation reports.Implement clinical studies by communicating with investigators & their staff, ensure compliance with sponsor/investigator obligations, train site personnel & write initiation visit reports.Supervise the conduct of clinical studies by acting as a liaison between site personnel & the sponsor; perform monitoring in the field; ensure compliance with protocol, regulatory requirements (FDA & Health Canada), ICH GCP & ISO14155 guidelines as well as local IRB requirements. Write follow-up visit reports.Ensure quality of projects: verify materials & data integrity, assisting site personnel with internal audits or regulatory inspections; & perform routine follow-up with in-house project teams.Collaboration with major functional areas to identify & evaluate integral issues on projects, evaluate root cause & ensure timely solutions.Assist with the direction of technical, protocol-specific & operational aspects of assigned trials.Close clinical studies: verify the integrity of investigator site files & trial master files; ensuring availability of clinical & non-clinical materials; review with investigators the obligations inherent at the end of the study & drafting closeout reports.Create clinical project documents, including, but not limited to: monitoring SOPs or plans, monitoring visit templates (reports & letters) as well as budgets.Verify data in (e)CRFs agree with source, initiate queries & ensure timely resolution of observations.Ensure compliance with the informed consent process.Ensure subject safety reporting to Sponsor & IRB.Verify receipt, handling, accounting & storage conditions of clinical products under investigationRespond to requests from investigators in a timely fashion.Draft appropriate intervention plans for the avoidance of redundant errors & deviations

  • INC Research
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Research Coordinator II
      • Oct 2014 - Nov 2014

      Took the overall lead & management of all required activities from study start-up to close out.Reviewed assigned protocols & other study documents (CRFs/eCRFs, IB, ICF, Source Documents etc.) for accuracy, feasibility, timing & resources.Supervised clinic visits as required & provided on-call support when applicable.In collaboration with responsible teams, ensured that all study related activities were conducted per protocol, SOP & applicable regulations.Reviewed & managed clinic updates, adverse event (AE) or serious adverse event (SAE) reporting, quality control & monitor findings.Ensured completion of closeout activities as required (complete ISF/TMF reconciliation, return of study supplies, IRB reports, archiving, etc.).

  • INC Research (Early Phase Unit - Toronto)
    • Clinical Research Coordinator
      • Sep 2011 - Sep 2014

      Clinical management of Abuse Liability, Alcohol Interaction, BA/BE, DDI, Dose Selection & First In Human studies; both single & multi-center trials.Provided direction & coordinated communication to project teams including: Recruiting, Clinical Resources, Monitoring, Project Management, Clinical Operations, Quality Assurance, Data Management, R&D as well as Finance.Clinical duties included: AE reporting, obtaining informed consent, vital signs measurements, qualitative drug screening, study drug administration, volunteer eligibility review prior to dosing &/or randomization.Responsible for managing patients & conducting clinical trials per study protocol, site SOPs & associated regulations while ensuring good clinical practice.Maintained communication with the Principal Investigator, Sub-Investigators and IRB to ensure all medical & study related information was relayed in a timely manner together with proper follow-up.Responsible for the educating/training of new & existing staff including the development of study specific training plans.Coordinated resolution & addressed QC, Monitor, CRF & other internal/external study findings.

  • Kendle Early Phase
    • Assistant Clinical Research Coordinator
      • 2009 - 2011

      Assisted in the coordination of clinical trials under the guidance of the Clinical Research Coordinator.Assisted with CRF/eCRF completion & review; tracked data entry completion to meet targeted deadlines.Assisted with resolution of data queries, quality findings, discrepancies & applicable data clarification forms in a timely manner. Assisted in the coordination of clinical trials under the guidance of the Clinical Research Coordinator.Assisted with CRF/eCRF completion & review; tracked data entry completion to meet targeted deadlines.Assisted with resolution of data queries, quality findings, discrepancies & applicable data clarification forms in a timely manner.

  • Decisionline
    • Research Associate
      • 2007 - 2009

      Provided support on clinical research studies by administering pharmacodynamic tests & other measures as appropriate.Completion of Case Report Forms (CRFs)/electronic Case Report Forms (eCRFs).Assisted with orienting data entry staff to protocol & study procedures as required.Helped with Pharmacodynamic user acceptance test (UAT) execution.Assisted with pharmacodynamic subject training.Performed electronic case report form UAT execution. Provided support on clinical research studies by administering pharmacodynamic tests & other measures as appropriate.Completion of Case Report Forms (CRFs)/electronic Case Report Forms (eCRFs).Assisted with orienting data entry staff to protocol & study procedures as required.Helped with Pharmacodynamic user acceptance test (UAT) execution.Assisted with pharmacodynamic subject training.Performed electronic case report form UAT execution.

Education

  • University of Toronto
    Honours BSc, Specialist in Cell and Molecular Biology
    2003 - 2007
  • University of California, Berkeley
    Clinical Research Conduct and Management, A (GPA ~3.93)
    2015 - 2016

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