Vidhatri Sahukar
San Jose,United States of America
Summary
"One Dynamic Year Can Outshine a Decade of Monotony" Results-driven and highly skilled Clinical Research Associate with a Master's in Clinical Research and a strong track record of independently managing 13 study sites across diverse therapeutic areas, including Oncology, Immunology, Neurology, Cardiovascular, and Hematology. Demonstrates expertise in protocol compliance, data integrity, and regulatory adherence, while fostering strong cross-functional collaboration. Experienced in leading all phases of site management—Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs)—with a focus on quality and efficiency.
Overview
6
6
years of professional experience
Work History
Clinical Research Associate II
ICON
03.2024 - Current
- Provide end-to-end operational oversight for 15 sites across 9 protocols from site initiation through close-out, ensuring adherence to GCP/ICH E6(R2), sponsor SOPs, and FDA/EMA regulatory requirements; drive inspection readiness and timeline discipline (FPI, LPO, DBL).
- Lead risk-based monitoring (RBM) activities, performing targeted SDV/SDR, data quality review, and issue trending in EDC; proactively escalate risks and implement CAPAs to protect subject safety, data integrity, and on-time milestones.
- Serve as primary site relationship manager and operational point-of-contact (sponsor/CRO site), delivering training on protocol, procedures, and systems during SIV/IMV/COV; reinforce enrollment strategies, visit cadence, and compliance expectations.
- Drive ethical and regulatory compliance by verifying IRB/IEC approvals, informed consent documentation, and version control; maintain continuous audit/inspection readiness through rigorous essential document review.
- Identify, document, and trend protocol deviations, AEs/SAEs, and non-compliance; collaborate with Safety for SAE reconciliation and ensure timely reporting per regulatory timelines.
- Produce decision-ready site visit deliverables (monitoring reports, follow-up letters, action logs) within required timelines; track and close actions to KPI and maintain an inspection-ready narrative across the study lifecycle.
- Oversee investigational product (IP) compliance, storage conditions, drug accountability, reconciliation, returns/destruction per protocol, pharmacy manual, and IWRS/IVRS controls; escalate temperature excursions and chain-of-custody issues.
- Coordinate cross-functionally (Data Management, Safety, Regulatory, Study Start-Up, Clinical Supplies, Central Labs, ePRO/eCOA vendors) to resolve data discrepancies, implement change control, and keep critical path tasks unblocked.
- Successful in managing eTMF/TMF quality (completeness, timeliness, and accuracy) and site regulatory binders, driving Veeva Vault/CTMS alignment with the study essential document list and TMF Reference Model expectations.
- Design and deliver training agendas (SIVs, refresher trainings, protocol amendments), tailoring content for PIs, coordinators, and pharmacy; verify training effectiveness via knowledge checks and reduction of repeated deviations.
- Monitor operational performance using KPIs/metrics, including data entry timeliness, query aging, deviation rates, enrollment rate, and visit compliance; present site-level trends and remediation plans in study team meetings/CPM.
- Initiate operational contract amendments (e.g., over-enrollment approvals, additional visits/procedures) and route to Contracts/Legal; validate CTMS for payment triggers and escalate discrepancies to Finance/CTM.
- Accomplishments
- Recognized by CRMD for exceptional diligence and attention to detail in identifying a delegated staff qualification gap and driving a proactive corrective action plan.
- Received commendation from the CPM for resolving three-year-old long-standing vendor queries and addressing consenting issues during a cross-functional study team and CRAM meeting.
Clinical Research Associate I
IHEALTH LABS
03.2022 - 02.2024
- Managed 4 end-to-end study site operations, overseeing activities ranging from site selection to on-site monitoring and close-out for Phase II, III, and 510K clinical trials.
- Assisted in the development and implementation of study-specific monitoring and reporting procedures, ensuring efficient and accurate data collection.
- Led the development of 4 clinical trial protocols and clinical study plans, actively participating in the review of draft protocols, consent forms, Clinical MOPs, and other IRB-related documents for study start-up.
- Conducted site qualification, 30 SIV's, 40 IMV's, and study 40 close-out visits, ensuring adherence to study protocols, IRB regulations, and ICH-GCP guidelines.
- Performed comprehensive risk assessments throughout the project, analyzing site health, evaluating site processes, and implementing necessary measures for project success.
- Developed a streamlined tool to facilitate the accurate transmission of clinical data to the data management team.
- Performed 100% Source Data Verification, data reconciliation and AE, SAE, SUSAR reports as required to ensure data integrity and protocol compliance.
- Designed and delivered >30 SIV training slides, effectively training site study staff on protocols and the completion of required documentation.
- Cross-functionally collaborated in the investigator meeting and initial business meetings, providing valuable assistance and feedback during site contract development and negotiation processes.
- Collaborated with investigators, study coordinators, and vendors to ensure effective study execution and timely completion of deliverables.
- Accomplishments
- Independent Project star Award
In-House CRA
FORTREA (PREVIOUSLY KNOWN AS LABCORP DRUG DEVELOPMENT)
02.2020 - 02.2021
- Supported and managed study databases, including Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), Electronic Data Capture (EDC), and study-specific SharePoint, ensuring data accuracy and accessibility.
- Prepared monitoring visit documentation for Clinical Research Associates (CRAs) and Project Managers (PMs), supporting the smooth execution of site visits and adherence to study protocols.
- Documented and maintained the project directory as requested, organizing and categorizing project-related materials for easy retrieval and reference.
- Conducted data entry and ensured the accurate maintenance of selected study tracking databases, contributing to the integrity and completeness of study data.
- Entered subject data as described by Principal Investigators (PIs) into the internal team tool, facilitating efficient data collection and management.
- Prepared study-related documents and materials for delivery to archives at appropriate intervals, ensuring compliance with regulatory requirements and proper documentation retention.
- Proactively initiated and organized various clubs, including Science Club and Communication Club, leading teams by planning and delegating weekly activities.
- Prepared presentations for study-related activities as requested by the project team, effectively conveying information and supporting knowledge sharing within the organization.
- Generated various reports as assigned by the 5 project team, such as site visit reports, training matrix reports, issue and risk reports, and QA log reports, contributing to effective project monitoring and management.
- Provided efficient clerical support to the 5 project team, including proofreading, editing correspondence, and assembling study documents, ensuring accuracy and adherence to project guidelines.
- Accomplishments
- Dynamic Team Leader and Mastermind of Innovation Award
- Pinnacle of All- Rounder Award
Education
Graduate, B.Pharm -
Jain University
Bangalore, Karnataka, India08-2019
Undergraduate, B.Pharm - undefined
Rajiv Gandhi University of Health Science
Mysuru, Karnataka, India05-2017
Skills
- Project management
- Site monitoring
- Accountability
- Completing regulatory documents
- Data collection
- Project monitoring
- Patient recruitment
- Quality control
- ICH GCP E6 (R3)
- Data evaluation
Languages/Fluency
English: High Conversational, High Reading, High Writing, High Medical Records/Terminology
Hindi: High Conversational, High Reading, High Writing, High Medical Records/Terminology
Timeline
Clinical Research Associate II
ICON
03.2024 - Current
Clinical Research Associate I
IHEALTH LABS
03.2022 - 02.2024
In-House CRA
FORTREA (PREVIOUSLY KNOWN AS LABCORP DRUG DEVELOPMENT)
02.2020 - 02.2021
Undergraduate, B.Pharm - undefined
Rajiv Gandhi University of Health Science
Graduate, B.Pharm -
Jain University
Protocol Therapeutic Experience
- Cardiovascular: Phase IIIB.
- Hematology (Malignant)Leukemia: Phase III
- Immunology: Phase III
- Infectious Diseases: Device Pre-Market
- Neurology (Neurodegenerative) Disorder: Phase III
- Oncology (Solid Tumors): Phase IIIB
System Experience
- Type: Clinical Trial Management Systems, System Name: CRIO, IMPACT CTMS, Medidata CTMS, Veeva Vault Clinical
- Type: EDC, System Name: Medidata RAVE
- Type: eSource/eCOA/eConsent, System Name: Clinical ink eCOA EX
- Type: IVRS/IWRS/RTSM, System Name: Cenduit, ISS Sponsor IVRS/IWRS/RTSM
- Type: Risk Based Monitoring, System Name: Medidata RAVE RBM
- Type: TMF, System Name: Veeva Vault ETMF
Vendor Experience
- Type: CRO, Name: Fortrea
- Type: EDC / eDiary / e-PRO, Name: Medidata
- Type: IXRS, Name: Cenduit
- Type: TMF Services, Name: Veeva Vault