LAKSHANYA VASUDEVAN

Role Performed: As CLINICAL RESEARCH COORDINATOR at

• Gastro-Intestinal Disease Management Group-(Oct 2023-Mar 2024

• Anesthesiology Unit (Apr 2024- Present)

• Facilitated trial-related activities of multiple Investigator Initiated Trials and Pharma-Sponsored Oncology trials from initiation to closure by ensuring adherence to Protocol, SOPs, GCP and regulatory and ethical standards.
• Assisted with PI for participant screening , recruitment of patients and Informed Consent processes including Audio-video consenting.
• Prepared and maintained regulatory documents for clinical trial submissions.
• Proficient in managing Trial Master Files (TMF).
• Performed data collection on e-CRF and developed reports for principal Investigators, contributed to 10+published research articles
• Certified in iMedidata, IBM SPSS, Redcap, and Octal Soft coordination for clinical data entry and management.
• Experienced and Trained on Site initiation visit /Routine/ Close-out monitoring visits by CRA’s for trial and Interim monitoring by data safety monitoring board (DSMB)/Auditors
• Participated investigator meetings, implementing trials following study timelines and budgets
• Gathered, processed, and shipped lab specimens.
• Monitored patient safety throughout clinical trials and reported any adverse events.
• Trained in resolving monitor's findings, CAPA management, budget formulation, IP accountability, and timely safety reporting of Adverse Event (AE)and Serious Adverse event (SAE)by assessing CTCAE 5.0 guidelines in SUGAM portal.
• Proficient in maintaining various logs- screening log, enrolment log, deviation/ violation log, SAE log, reimbursement log.
• Prepared MoU for Foreign Collaboration centres for FCRSC approval and Bio-RAAP ID generation for data transfer, CTRI registration.
• Familiar with IWRS/IVRS software (Octal Soft IWRS, CLIN phone -Calyx IRT) and Clario e-Research Technology (ERT)ePRO, AMBRA medical image management system, Pfizer SIRIUS portal.

Role Performed: MEDICAL WRITER : Skilled in writing scientific documents such as Protocols, Informed Consent Forms, Case Record Forms, and Manuscripts for Journal Publications.

Role Performed : As Clinical Trial Monitor

• Trained to Monitor the conduct of clinical trials especially assessing participant eligibility and ensuring integrity and quality of collected data.
• Reviewed CRF, Informed Consent Documents and narratives and Source documents.
• Ensured completeness of Logs and thorough study drug reconciliation.
• Reconciled between TMF and SMF , ensured communication requirements are present between site and IRB.
• Developed Clinical Monitoring Plans with review from CRA Manager.
• Prepared Monitoring Report and Follow-up letter.
• Performed Internal Quality control check of 10+studies and prepared Monitoring Report.

Role Performed : As Phase-1 Trail Unit Coordinator

Advance Centre for Treatment Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai.

• Coordinated the execution of Phase I clinical trials and assisted in EC dossier submission for review and approval by IEC/IRB approval.
• Assisted in screening, enrolment and obtained ICF from Phase-I trial participant and collection of Pharmacokinetics (PK) and Pharmacodynamics (PD) blood samples.
• Contributed to data acquisition and study progression.
• Performed Safety Reporting (AE/SAE) to the Drug Controller General of India (DCGI)
• Identified improvement and contributed to development of standard operating procedures (SOPs) for Phase I trial management.

(INDUSTRY EXPERIENCE)

• Acquired comprehensive understanding of clinical operations processes from the sponsor’s perspective, encompassing study initiation, execution, and closeout phases.
• Observed and familiarized myself with various clinical trial management systems (CTMS), electronic Trial Master File (e-TMF), centralized monitoring, and risk-based monitoring techniques.
• Gained exposure to drafting monitoring reports, developing data handling plans, and managing data using Electronic Data Capture (EDC) software.
• Learned about outsourcing specifications with Contract Research Organizations (CRO) and Site Management Organizations (SMO), Vendor management , pharmacovigilance processes using Vigiflow and safety management with iMedidata Rave EDC.
• Acquired knowledge in Investigational Product (IP) management through Interactive Response Technology (IRT) processes and participated in budget preparation activities.
• Developed professional communication skills and interpersonal abilities vital for industry.

• Observed and actively contributed to the operations of the IEC/IRB committee within an oncology setting.
• Contributed to the review process of trial related documents, amendments submitted for IRB approval.
• Ensured confidentiality and accuracy, completeness of documentation by adhering to ethical and regulatory standards
• Facilitated communication between committee members and Investigators
• Facilitated communication between committee members and Investigators

Role Performed: As Clinical Trial Assistant/ coordinator at

Solid tumor Unit •Breast Disease Management Group

•Adult Hematolymphoid Unit •Palliative Medicine.

• Collected and maintained patient demographics, medical histories, laboratory results, adverse events reporting and 10+clinical research data on e-CRF/paper CRF.
• Hands-on experience with Electronic Medical Records (EMR), Source Documentation and Electronic Data Capture (EDC) systems with reduced data entry errors by 92%.
• Proficient in preparing Prepared and maintained essential study documents, including protocols, informed consent forms (ICFs), case report forms (CRFs), and MoU, Budget of the study.
• Trained on preparing, reviewing, and submissions of Initial and Post approval amendments of trial documents (EC dossier), SUSARs, Continuous Review Application (CRA), Deviations, Study close out report (SCR).