Jyoti Prakash Doda

- Conduct all clinical site activities according to the monitoring plan and within recommended timeline.

- Work closely with the sponsor of each study and ensure all trial related activities are met in accordance with ICH-GCP.

- To conduct the Site selection visit, Site initiation visit, Interim monitoring visit and close out visit.

- To prepare the monitoring visit report and follow up letter within stipulated time period as mentioned in the clinical monitoring plan.

- Assist the site to resolve the open action items and EDC queries.

- Work with the Payment team to reconcile the site payment.

- Prepare the site for audit readiness.

• Ensure site monitors (CRAs) are performing the site monitoring visits according to monitoring plan, assigned SOPs and ICH-GCP guideline.
• To review and approve the site monitoring reports and follow-up letters in stipulated time period as published in monitoring plan.
• Review the site escalations and suggest the efficient corrective and preventive action (CAPA) to close the issue on time.
• Ensure the CRAs are doing regular follow-up with assigned sites to close the issue and risks.
• Liaise with clinical lead and project lead to communicate any trends, outstanding issues, safety concerns or any other activity which may jeopardize the clinical trial delivery or patient safety.
• Review the protocol deviation according to protocol deviation handling plan and suggest the efficient CAPA.

• Leading the functional responsibilities for assigned project and ensure project timelines & clinical deliverables are met.
• Manage & oversee the unit hour forecasting for project CMS team.
• Facilitate project kick-off, weekly and client meetings.
• Assist the clinical lead and project lead for 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 virtual ISF binder of the assigned countries.
• Review the protocol deviation as per the protocol deviation handling plan.
• Review he site visit reports as and when require.
• Review and manage the country level and site level eTMF.
• Review and approve the investigator payment.

• Monitor the CRAs activities in coordination with project manager to ensure the timelines, deliverables and quality standards are met as per sponsor requirements.
• To share the site status updates to client.
• Negotiate the study budget with investigator / project vendors and ensure that timely payments are made to them.
• Responsible for study update and coordination with central/local labs & other trial related service provider as per the requirements.
• Ensure proper escalation and management of site/project related issues to project manager / designee on timely manner.
• To liaise with other department within organization to timely achievement of the project milestones.
• Responsible for training of project team (CRAs and CTAs) regarding monitoring plan, maintenance of essential documents and for start-up activities.
• Perform site monitoring visits including site qualification visit, site initiation visit, routine monitoring visit and site close out monitoring visit.
• Review and finalization of monitoring visit reports of CRAs within given timeline.
• Mentoring and guiding the project team for efficient working/issue management in consultation with project manager.

• To impart training and mentoring the clinical trial assistant, clinical research associate and Sr. clinical research associate to perform the project related activities.
• Review and finalization of monitoring visit reports of CRAs and managing respective site issues.
• Co-ordinate with external vendors for project related supplies.
• To organize the project status to client.
• Participating in regular project team meetings/discussions and also in inter-department meetings.
• To escalate the critical issues to project team.

• Perform the site monitoring visits including site qualification visit, site initiation visit, routine monitoring visit and site close out monitoring visit as per the monitoring plan.
• To prepare the site monitoring report and follow up letter within timeline as recommended in 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 the training to investigators and site staff on protocol, obtaining consent, screening/randomization procedures, EDC, SAE reporting, IMP storage and IP accountability.
• Organize the sites for inspection and audits.
• Implement of corrective and preventive action (CAPA) at site after identification of any non-compliance and ensure the issue do not occur in future.
• Management and review of investigator site file and trial master file.

• Identify and implementing vendor selection programs to ensure that the best vendor is secure for the ongoing projects/operations in organization
• Coordinating with operation manager to understand the requirement of service and products.
• To conduct interviews with new vendors and informing approved vendor of their responsibilities and obligation
• Prepare MoM (Minutes of meetings) and send to relevant stakeholders after meeting
• Collaborate with finance team in generating purchase orders and payments, tracking annual spend, revenue and cost saving

• Identification and selection of clinical project sites for assigned project/protocol in consultation with 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/issues raised by site staff in timely manner for smooth conduct of project.
• Negotiate the financial contract with principal investigators.
• Assist the site staff to resolve the query raised in case report form.

• To manage the routine clinical project activities and play a critical role in conduct of project at clinical site
• Draft and oversee the clinical trial agreement and submit to ethics committee for review
• Set up the infrastructure at site according to project requirements
• Participate in informed consent discussion with subjects to explain them non-clinical part
• Update the source documents for non-clinical aspects
• Coordination with study subjects for scheduling the site visits
• Update the investigator site file with essential documents
• Archival of project records after close out as per applicable policy/guidelines or contract

• To perform the SIV, routine monitoring visits and close out monitoring visits under the supervision of 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

• To perform the in-house monitoring visit
• Prepare the follow up letter and monitoring report in stipulated time period.