Summary
Overview
Work History
Education
Skills
Publications
Therapeutic Experience
Certification
Timeline
Generic

Bhushan Kulkarni

Central Report Reviewer
Aurangabad

Summary

I am currently working as Central Report Reviewer. Additionally, I have more than 9-year(s) of experience in the Contract Research Organization (CRO) Industry as a Central Monitor, Site Report Specialist, CRA working on Phase (I-IV).

Overview

11
11
years of professional experience
1
1
Certification
3
3
Languages

Work History

Central Report Reviewer

Syneos Health
05.2024 - Current
  • Responsible for execution of Central Report Review activities on the study based on the Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
  • May support development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN
  • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
  • Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations/special Sponsor's requirements and pharmacovigilance issues documented in the report. Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager
  • Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary in appropriate systems for action by CRA/CM or other functional team members.
  • May assesses CRA/CM report quality, risks, and trends as well as operational performance and summarizes the findings for CTM review and action planning.
  • Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements. Involves in regular project discussion and email correspondence to maintain the most up-to-date project status knowledge and progression.
  • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
  • May support in CTM activities such as Protocol Deviation management, Action Items management, etc

Central Review Manager

PPD
07.2022 - 04.2024
  • Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and/or preventative action plans are documented and followed up to resolution, to ensure high quality reports.
  • Participate on the project team for all SVR review activities and identifies and escalate CRA and/or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
  • Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations.
  • Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.
  • Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log.
  • Provide coaching to decrease the level of corrections/additions needed on reports.
  • Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members.
  • May take on special project assignments related to function/corporate initiatives.

Clinical Research Associate

CMR Surgical India Pvt Ltd.
01.2020 - 07.2022
  • Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.
  • Liaising with doctors/consultants or investigators on conducting the trial.
  • Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.
  • Verify that investigator and investigator’s team are adequately trained and comply with the protocol.
  • Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.
  • Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.
  • Source data verification
  • Informed consent form review, case report form review, investigational drug accountability, and adverse event review.
  • Ensuring all unused trial supplies are accounted for.
  • Writing visit reports, filing, and collecting trial documentation and reports.

Associate Site Report Specialist

IQVIA RDS India Pvt Ltd
06.2018 - 01.2020
  • Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and/or preventative action plans are documented and followed up to resolution, to ensure high quality reports.
  • Participate on the project team for all SVR review activities and identifies and escalate CRA and/or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
  • Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations.
  • Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.
  • Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log.
  • Provide coaching to decrease the level of corrections/additions needed on reports.
  • Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members.
  • May take on special project assignments related to function/corporate initiatives.

Central Monitor

IQVIA RDS India Pvt Ltd
06.2016 - 12.2018
  • Manage assigned studies with minimal supervision.
  • Attend study team meetings as needed or requested.
  • Contribute to the development and use of study management plans and/or DTE specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study.
  • Support project management team to develop monitoring strategy including monitoring triggers/thresholds.
  • Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage, and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)
  • Contribute to developing the study specific analytics strategy and/or work on developing advanced analytics.
  • With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
  • Identify the value adds from the medical review & remote monitoring in the study and provide the inputs to relevant stakeholders.
  • Support CL to perform oversight on clinical deliverables of assigned projects as per the protocol, SOPs, respective regulation/guidelines, and project Clinical Operations Plan.
  • Manage project resources (CRAs/ CTAs/Centralized Monitoring team).
  • Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).
  • Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.
  • Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
  • Perform Management of triggers and preparation of I-site pack for respective sites and countries for assigned study.
  • In collaboration with data owners and functional managers, contribute to development of data analysis methods and procedures for mining study data, performing the trend analytics for their respective study.
  • Participate in (study) team meetings/Project kick off meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items.
  • Escalate quality issues pertaining to site and/or subject to respective stakeholder within the project team.
  • Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.
  • Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team.
  • Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
  • Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk.
  • Monitor site performance and make recommendations for timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit)
  • Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.
  • Work in accordance with the Study Central Monitoring Plan
  • Establish and maintain effective project/ site level communications with relevant stakeholders.

Clinical Research Coordinator

Excel Life Sciences Pvt Ltd
06.2016 - 01.2018
  • Complete the source documents as well as the EDC entry. Follow-up with the patients on their study visits
  • Involved in the AV consenting procedure.
  • Timely reporting the AE/SAE to Ethics committee Maintain the Investigator site file.
  • Communicate with ethics committee for study update Do the cross-referral activity for new patient.
  • Conduct the feasibility to find out suitable doctors for the study.

Clinical Research Coordinator

Healing Hands Clinical Research Services
09.2014 - 06.2016
  • Complete the source documents as well as the EDC entry. Follow-up with the patients on their study visits
  • Involved in the AV consenting procedure.
  • Timely reporting the AE/SAE to Ethics committee Maintain the Investigator site file.
  • Communicate with ethics committee for study update Do the cross-referral activity for new patient.
  • Conduct the feasibility to find out suitable doctors for the study.

Education

Master of Science - Biotechnology

MGM Institute of Biosciences & Technology
04.2001 -

Bachelor - Biotechnology

MGM Institute of Biosciences & Technology
01.2012

Skills

Multitasking

Database maintenance

Teamwork

Time management

Data entry

Time management abilities

Clear communication

Publications

  • Evaluation of Stability Study of Laxative Ayurvedic Formulation Constac Plus Granulation in International Journal of Ayurveda and Pharmaceutical Chemistry, Jan 2016
  • Published Research Article titled A Stability Study of Ayurvedic Laxative Formulation - Constac Granulation in International Journal of Ayurveda and Pharma Research, Oct 2015

Therapeutic Experience

  • Device - Gynecological Disorder Device
  • Gastroenterology - Dyspepsia
  • Nephrology - Kidney Disease, Chronic
  • Oncology - Vaccine
  • Ophthalmology - Uveitis

Certification

“ Evaluation of Stability Study of Laxative Ayurvedic Formulation Constac Plus Granulation” in International Journal of Ayurveda and Pharmaceutical Chemistry, Jan 2016

Timeline

Central Report Reviewer

Syneos Health
05.2024 - Current

Central Review Manager

PPD
07.2022 - 04.2024

Clinical Research Associate

CMR Surgical India Pvt Ltd.
01.2020 - 07.2022

Associate Site Report Specialist

IQVIA RDS India Pvt Ltd
06.2018 - 01.2020

Central Monitor

IQVIA RDS India Pvt Ltd
06.2016 - 12.2018

Clinical Research Coordinator

Excel Life Sciences Pvt Ltd
06.2016 - 01.2018

“ Evaluation of Stability Study of Laxative Ayurvedic Formulation Constac Plus Granulation” in International Journal of Ayurveda and Pharmaceutical Chemistry, Jan 2016

05-2016

Clinical Research Coordinator

Healing Hands Clinical Research Services
09.2014 - 06.2016

Master of Science - Biotechnology

MGM Institute of Biosciences & Technology
04.2001 -

Bachelor - Biotechnology

MGM Institute of Biosciences & Technology

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Bhushan KulkarniCentral Report Reviewer