Ajay Jakhar

Clinical research professional with 2+ years of hands-on experience supporting Phase I–IV clinical trials across Sponsor and CRO environments, recently promoted to Clinical Research Associate (CRA) for three ongoing studies. Skilled in maintaining Trial Master File (TMF) and electronic Trial Master File (eTMF), conducting quality review and completeness checks of essential documents against ICH-GCP and ALCOA+ principles, and coordinating site start-up, monitoring, and close-out activities, including co-monitoring Site Initiation Visits (SIVs). Experienced with CTMS and EDC systems, SAE/AE reporting, and regulatory submissions under DCGI/NDCT requirements.

Proficient in MS Word, Excel, PowerPoint, and Outlook, with strong organizational, cross-functional coordination, and time-management skills.

Clinical Research Associate (Promoted) - CliniExperts Research Services Pvt. Ltd. - Dwarka, New Delhi

(2024-02)

Currently managing 3 studies. Promoted from Clinical Trial Assistant to Clinical Research Associate in recognition of performance; currently responsible for site monitoring activities across 3 clinical studies.

• Promotion: Promoted from Clinical Trial Assistant to Clinical Research Associate in recognition of performance; currently responsible for site monitoring activities across 3 clinical studies.
• SIV Co-Monitoring: Co-monitored fellow CRAs during Site Initiation Visits (SIVs), supporting site readiness assessment, regulatory and essential document verification, and investigator/site staff training on protocol and study procedures.
• Site Monitoring: Conduct co-monitoring visits to verify source data, regulatory compliance, and adherence to ICH-GCP and ALCOA+ principles at investigator sites.

Clinical Trial Assistant - CliniExperts Research Services Pvt. Ltd. - Dwarka, New Delhi

(2024-02)

• TMF/eTMF Ownership: Maintained and organized Trial Master File (TMF) and Investigator Site Files (ISF), performing quality review and completeness checks against company, sponsor, and ALCOA+ standards to ensure audit readiness.
• Quality & Compliance: Ensured trial conduct complied with ICH-GCP guidelines, study protocols, SOPs, and applicable DCGI/NDCT regulatory requirements.
• Site Start-Up Support: Supported study start-up activities including site selection, ethics committee submissions, and investigator documentation.
• Study Tracking: Tracked study progress, patient enrolment, and site performance using Clinical Trial Management Systems (CTMS); maintained study trackers, logs, and dashboards for milestones and deliverables.
• Cross-Functional Coordination: Coordinated communication between sponsors, CROs, investigators, and site staff; scheduled and supported investigator meetings, monitoring visits, and audits.
• Document Management: Assisted in preparation, review, and distribution of essential study documents (protocols, informed consent forms, case report forms) and supported document version control.
• Safety Reporting: Ensured timely reporting and documentation of Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Data Management: Supported data entry, query resolution, and data validation activities in Electronic Data Capture (EDC) systems.
• Logistics: Managed clinical trial supplies, shipments, and inventory tracking; provided administrative support including meeting minutes and filing.

Diploma - Clinical Research - Apollo Hospital & DPSRU (2024)

M.Sc. - Botany - Baba Mastnath University (2022)

B.Sc. - Maharishi Dayanand University (2020)