Jyoti Prakash Doda
Sydney,NSW
Summary
More than 14 years of experience in the clinical research industry, including on-site/remote monitoring, project management, and risk-based monitoring of clinical trial projects.
Managed global clinical trials (Phase I/II/III/IV) in various therapeutics, viz. Infectious, Oncology, Respiratory, Cardiovascular, Dermatology, Gastrointestinal, and Assisted reproductive technology (IVF) in various roles' capacity.
Worked as a Site Monitor and executed the monitoring of 150+ SQV, 100+ SIV, 500+ IMV, and 50+ SCV.
Reviewed approximately 200 site monitoring visit reports. Onsite clinical trial monitoring exposure in multiple countries: Thailand, Egypt, and the UAE.
Facilitate 07 sponsor audits.
Mentoring for the clinical trial monitoring team since 2019.
Authorized to work in Australia under permanent residency visa grant, subclass 190.
Overview
16
16
years of professional experience
Work History
Sr Clinical Research Associate II
Avance CRO
Sydney
10.2024 - 04.2025
- Perform all activities (preparation, execution, and follow-up) associated with onsite Pre-Study Visit (PSV), Study Initiation Visit (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV), and Close-Out Visit (CoV).
- Conduct site and investigator feasibility activities.
- Generate and maintain high-quality confirmation letters, site visit reports, follow-up letters, and other documentation related to site monitoring and management to ensure compliance with ICH-GCP, study protocol, and regulatory requirements.
- Monitor participant source data, review the Investigator Site File (ISF), perform investigational product accountability, meet with site personnel, and ensure procedures are conducted in accordance with the protocol and ICH-GCP.
- Raise data queries in the Case Report Form where discrepancies are identified, and work with site staff to ensure timely and accurate resolution.
- Collect TMF documentation from the site, and ensure accurate and timely filing as per SOP requirements.
- Participate in study-specific or vendor audits conducted by the sponsor or regulatory agencies, and respond to audit observations, as required.
- Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
- Provide guidance and mentoring to less-experienced staff during co-monitoring visits, and facilitate accompanied site visits.
Sr. Clinical Research Associate
Novotech CRO
Sydney
12.2023 - 10.2024
- Monitor the activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols.
- Carry out the site selection, site initiation, interim site monitoring, and close-out monitoring visits as per the sponsor-approved monitoring plan. Plan and schedule the site monitoring/pharmacy visit, and share the confirmation letter.
- Prepare the site monitoring visit report and get it approved by the reviewer within the stipulated timeline, as per the monitoring plan.
- Follow up with site staff to resolve the open action items and open EDC queries. Review the Trial Master File and collect the essential documents from the site.
- Plan and track study/site milestones. Train the investigator and site staff on protocol, obtaining informed consent, screening/randomization procedures, SAE reporting, and IMP storage and accountability procedures.
- Maintain tracking records for assigned sites, such as tracking the status and source document, and eCRF review per patient. Organize the sites for inspections and audits. Work with the Payment team to reconcile the site payment. Prepare the site for audit readiness.
Centralized Trip Report Reviewer II
Fortrea Development India Private Limited
Gurgaon, Haryana
07.2023 - 10.2023
- Ensure site monitors (CRAs) are performing the site monitoring visits according to the monitoring plan, assigned SOPs, and ICH-GCP guidelines.
- To review and approve the site monitoring reports and follow-up letters in the stipulated time period, as published in the monitoring plan.
- Review the site escalations and suggest the efficient corrective and preventive actions (CAPA) to close the issue on time.
- Review the site escalations and suggest the efficient corrective and preventive actions (CAPA) to close the issue on time.
- Ensure the CRAs are doing regular follow-ups with assigned sites to close the issues and risks.
- Liaise with the clinical lead and project lead to communicate any trends, outstanding issues, safety concerns, or any other activity that may jeopardize the clinical trial delivery or patient safety.
- Review the protocol deviation according to the protocol deviation handling plan, and suggest the efficient CAPA.
Sr. Centralized Monitoring Lead
IQVIA RDS Pvt. Ltd.
Gurgaon, Haryana
02.2022 - 07.2023
- Manage and oversee the unit hour forecasting for the project CMS team.
- Facilitate project kick-off, weekly, and client meetings.
- Assist the clinical lead and project lead in the preparation of clinical management plans.
- Maintain and oversee the site-level matrix of the assigned countries.
- Oversee the monitoring visit compliance.
- Create and maintain a virtual ISF binder of the assigned countries.
- Review the protocol deviation as per the protocol deviation handling plan.
- Review the site visit reports as and when required.
- Review and manage the country-level and site-level eTMF.
- Review and approve the investigator's payment.
Principal - Clinical Research Associate
SIRO Clinpharm Pvt. Ltd
Mumbai, Maharashtra
01.2020 - 02.2022
- To share the site status updates with the client.
- Negotiate the study budget with the investigator, project vendors, and ensure that timely payments are made to them.
- Responsible for study updates and coordination with central/local labs, and other trial-related service providers, as per the requirements.
- Ensure proper escalation and management of site/project-related issues to the project manager or designee in a timely manner.
- To liaise with other departments within the organization to ensure the timely achievement of the project milestones.
- Responsible for training the project team (CRAs and CTAs) regarding the monitoring plan, maintenance of essential documents, and start-up activities.
- Perform site monitoring visits, including site qualification visits, site initiation visits, routine monitoring visits, and site close-out monitoring visits.
- Review and finalize the monitoring visit reports of CRAs within a given timeline.
- Mentoring and guiding the project team for efficient working and issue management in consultation with the project manager.
Clinical Team Lead - Clinical Operation
Cliantha Research
Ahmedabad, Gujrat
06.2019 - 01.2020
- Review and finalization of monitoring visit reports of CRAs, and managing respective site issues.
- Coordinate with external vendors for project-related supplies.
- To organize the project status for the client.
- Participating in regular project team meetings, discussions, and also in inter-department meetings.
- To escalate the critical issues to the project team.
Sr Clinical Research Associate
SIRO Clinpharm Pvt. Ltd.
Mumbai, Maharashtra
05.2017 - 05.2019
- To prepare the site monitoring report and follow-up letter within the timeline as recommended in the monitoring plan.
- Resolve site issues as they affect clinical plan timelines and quality, to ensure the achievement of goals and objectives at the site level.
- To impart training to investigators and site staff on the protocol, obtaining consent, screening/randomization procedures, EDC, SAE reporting, IMP storage, and IP accountability.
- Organize the sites for inspection and audits.
- Implement corrective and preventive action (CAPA) at the site after identifying any non-compliance, and ensure the issue does not occur in the future.
- Management and review of the investigator site file and the trial master file.
Sr. Executive - Vendor Management
Mealdom LLP
Gurgaon, Gurgao
06.2014 - 04.2017
- Coordinating with the operations manager to understand the requirements of services and products.
- To conduct interviews with new vendors and inform approved vendors of their responsibilities and obligations.
- Prepare the MoM (Minutes of Meetings) and send it to the relevant stakeholders after the meeting.
- Collaborate with the finance team in generating purchase orders and payments, tracking annual spend, revenue, and cost savings.
Clinical Research Executive (CRA)
Apothecaries Pvt. Ltd.
Gurgaon, Haryana
07.2011 - 05.2014
- Identification and selection of clinical project sites for the assigned project/protocol, in consultation with the project manager.
- Perform the site initiation visit, routine monitoring visits, and site close-out visit as per the monitoring plan.
- Preparation of monitoring visit reports and follow-up letters.
- Respond to all queries and issues raised by site staff in a timely manner for the smooth conduct of the project.
- Negotiate the financial contract with principal investigators.
Sr. Site Coordinator
Kansal Skin and cosmetic clinic
Jaipur, Rajasthan
02.2011 - 07.2011
- To manage the routine clinical project activities and play a critical role in the conduct of the project at the clinical site.
- Draft and oversee the clinical trial agreement, and submit it to the ethics committee for review. Set up the infrastructure at the site according to project requirements.
- Participate in an informed consent discussion with subjects to explain the non-clinical part, and update the source documents for non-clinical aspects.
- Coordination with study subjects for scheduling the site visits, updating the investigator site file with essential documents, and archiving project records after closeout as per applicable policy, guidelines, or contract.
Trainee Clinical Research Associate
Sanofi Pasteur (India) Pvt. Ltd
Delhi, Delhi
12.2009 - 07.2010
- To perform the SIV, routine monitoring visits, and close-out monitoring visits under the supervision of the project manager.
- To prepare the monitoring reports and follow-up letter.
- Coordinate with CRO team members and confirm the monitoring schedule and clinical trial supplies update at sites. Ensure the site coordinators are completing the CRFs on time.
Clinical Research Associate
ACE Biomed
Mumbai, Maharashtra
05.2009 - 12.2009
- To perform the in-house monitoring visit.
- Prepare the follow-up letter and monitoring report in the stipulated time period.
Education
Post Graduate Diploma in Pharmaceutical Management - Clinical Research
Academy of Pharmaceutical Management
Mumbai (India)05-2009
Associate of Applied Science - Bachelor of Pharmacy
Seth G.L. Bihani S.D. College of Tec Edu
Shri Ganganagar (India)01-2006
Skills
- Site monitoring
- Trial master file
- Site feasibility
- Adverse event reporting
- Project management
- Audit preparation
- Training and mentoring
- Communication skills
- Problem solving
- Clinical Protocol Compliance
- Study monitoring
- Accountability
- Trip reports
- Good clinical practice
- CTMS: Veeva Vault, Sibel CTMS); eTMF (Wingspan and Veeva Vault) EDC Platform (Medidata RAVE, Inform and Agcapture) Lab portals (Q2 solution) IWRS Clinical Trial supplies Almac) Clinical Analytics Tools
Timeline
Sr Clinical Research Associate II
Avance CRO
10.2024 - 04.2025
Sr. Clinical Research Associate
Novotech CRO
12.2023 - 10.2024
Centralized Trip Report Reviewer II
Fortrea Development India Private Limited
07.2023 - 10.2023
Sr. Centralized Monitoring Lead
IQVIA RDS Pvt. Ltd.
02.2022 - 07.2023
Principal - Clinical Research Associate
SIRO Clinpharm Pvt. Ltd
01.2020 - 02.2022
Clinical Team Lead - Clinical Operation
Cliantha Research
06.2019 - 01.2020
Sr Clinical Research Associate
SIRO Clinpharm Pvt. Ltd.
05.2017 - 05.2019
Sr. Executive - Vendor Management
Mealdom LLP
06.2014 - 04.2017
Clinical Research Executive (CRA)
Apothecaries Pvt. Ltd.
07.2011 - 05.2014
Sr. Site Coordinator
Kansal Skin and cosmetic clinic
02.2011 - 07.2011
Trainee Clinical Research Associate
Sanofi Pasteur (India) Pvt. Ltd
12.2009 - 07.2010
Clinical Research Associate
ACE Biomed
05.2009 - 12.2009
Post Graduate Diploma in Pharmaceutical Management - Clinical Research
Academy of Pharmaceutical Management
Associate of Applied Science - Bachelor of Pharmacy
Seth G.L. Bihani S.D. College of Tec Edu
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