Shanti Persaud
Queens
Summary
Dynamic Clinical Research Supervisor with extensive experience at Memorial Sloan Kettering Cancer Center, excelling in regulatory compliance and quality assurance. Proven track record in managing diverse teams, enhancing operational efficiency, and ensuring audit readiness. Adept at budget management and fostering stakeholder collaboration, driving successful clinical trial outcomes.
Overview
15
15
years of professional experience
Work History
Clinical Research Supervisor
Memorial Sloan Kettering Cancer Center
09.2021 - Current
- Supervised daily operations of a research team comprising 12 members, including CRCs, CRSps, CRAs, and indirect oversight of Research Regulatory Associates, ensuring compliance with institutional and regulatory standards.
- Managed quality assurance of research documentation, patient visit data, and assessments, supporting audit readiness and regulatory adherence.
- Facilitated IRB submissions, including Single Patient Use (SPU) protocols, and liaised with external funders, IRB, pharmacy, and internal teams to ensure timely approval, treatment, and closure—demonstrating strong regulatory and administrative coordination.
- Coordinated and submitted contractual documents such as DUAs, MTAs, and DTAs into electronic systems, ensuring compliance with sponsor requirements and institutional policies.
- Collaborated with stakeholders—PIs, clinical staff, finance teams, IRB, and sponsors—to support study initiation, management, and compliance activities, fostering effective communication and operational efficiency.
- Led staff development through hiring, onboarding, and training, promoting adherence to research standards and operational procedures.
- Supported study startup activities, including feasibility assessments, site selection, and facilitating contractual agreements, ensuring alignment with project timelines and budgets.
- Managed operational workflows for IRB submissions, amendments, and continuing reviews, maintaining meticulous records of regulatory compliance.
- Developed and maintained study documentation, including regulatory files, budgets, and effort commitments, ensuring accuracy and audit readiness.
- Utilized research management systems (CTMS) and financial reports to monitor study progress, budget adherence, and resource allocation, supporting corrective actions as needed.
- Led team meetings, prepared agendas, and coordinated training initiatives to enhance operational capacity and compliance.
- Supported financial and regulatory aspects of research, including effort tracking, reconciliation, and documentation, aligning with institutional policies and sponsor guidelines.
- Facilitated communication with sponsors regarding payments and contractual obligations, ensuring transparent and compliant financial transactions. Supervise day to day activities of 12 research team members including Clinical Research Coordinators, Clinical Research Specialists, Clinical Research Associates, and indirect supervision to Research Regulatory Associates in DSSM
- Performed quality checks of staff research work, including patient visit data, EDC, and research assessments during weekly 1:1 meetings.
- Work closely with staff to prep for monitoring visits as well as internal/ external audits and submit SAEs internally and externally
- Prepare and submit Single Patient Use submissions to the IRB and liase between external drug funder, internal clinical team, IRB, and pharmacy to follow SPU through approval, treatment, and closure. Also work with the IND and contracts department in tandem.
- Created an SPU workflow for Infectious Diseases submissions
- Submit DUAs, MTAs, DTAs, ect into Ironclad/ Econtracts as appropriate for PIs in 4 DSSM services
- Provide direct support and liaison between various stakeholders including PIs, clinical study staff, finance staff, IRB support, and pharmaceutical sponsors
- Contributed to staff development by actively participating in hiring, onboarding, and training processes for CRCs, CRSps, and CRAs.
- Prep and submit new studies to Protocol Activation Core and also work directly with PAC during activation process as needed
- Coordinate and lead team meetings including preparing agendas, meeting minutes, and presentations
- Provide start up support through feasibility, site selection visits, facilitate CDAs, DTAs, ect
- Collaborate with key stakeholders (internal and external) in the development and ongoing management of clinical trials and research projects, including investigator initiative trials, industry-sponsored trials, biospecimen protocols, and retrospective protocols
- Communicate with sponsors to reconcile payments as needed
- Perform TMF reconciliation along with regulatory team support
- CTMS - calendar builds and approve protocol builds
- Develop training programs for new department initiatives (including recruitment efforts, the QA process, and audit preparedness)
- Facilitate IRB submissions including continuing review reports, amendments, new protocol submissions, DSMC reports, and protocol deviations)
Clinical Trials Assistant (part time, contract position)
Clinilabs Pharmaceuticals
05.2022 - 10.2023
- Assist in the collection, maintenance, and management of regulatory documents, ensuring accuracy and compliance for audit readiness.
Oversee Electronic Trial Master File (eTMF) management and conduct regular reviews to ensure completeness and regulatory adherence.
Prepare TMFs for closeout visits by working directly with CRAs to identify and notify teams of missing documents, facilitating smooth site closures.
Schedule and coordinate internal and external meetings, including study team meetings, regulatory reviews, and audit preparations.
Develop and distribute meeting agendas, record detailed minutes, compile post-meeting action item lists, and prepare presentations to support effective communication and follow-up.
Prepare and submit protocol amendments, study closure documentation, and continuing review applications to the IRB via the Advarra portal, ensuring timely and compliant submissions.
Maintain comprehensive study management trackers, including recruitment timelines, site contact lists, financial expenditure logs, and IRB submission status, to support ongoing study oversight and fiscal accountability.
Collaborate with financial teams to monitor study budgets, track expenses against funding allocations, and support cost reconciliation efforts to ensure financial compliance and transparency.
Clinical Research Manager
Icahn School of Medicine at Mount Sinai Hospital
02.2020 - 09.2021
- Managed a team of Clinical Research Coordinators across four therapeutic areas—Immunology, Hepatology, Rheumatology, and Nephrology—ensuring effective team coordination, adherence to protocols, and regulatory compliance.
- Coordinated and conducted Protocol Safety and Skills Verification (PSSV) and Site Initiation Visits (SIV) between clinical trial sponsors and site staff, supporting seamless trial startup and ongoing operations.
- Developed and authored SOPs during the COVID-19 pandemic to adapt clinical trial procedures to the evolving environment, ensuring continued compliance and operational flexibility.
- Led efforts to enhance study visibility and participant recruitment by posting study advertisements on social media, hospital sites, and other community forums, increasing enrollment and awareness.
- Managed protocol development and oversight of study documentation, including regulatory submissions, amendments, and study-specific procedures.
- Collaborated with finance teams to develop budgets for new protocols and amendments, tracking expenses and supporting financial planning for study activities.
- Worked with study teams—including coordinators, CRAs, and PIs—to develop recruitment plans for new and ongoing protocols, addressing logistical challenges and retention obstacles proactively.
Performed regular quality assurance checks of subject binders and regulatory files to ensure adherence to Good Clinical Practice (GCP) standards and regulatory requirements. - Ensured all trials were conducted in strict accordance with approved protocols, SOPs, FDA regulations, and ICH/GCP guidelines, maintaining high standards of study integrity.
Experienced with systems such as Epic EMR, OnCore CTMS, Florence e-binder, REDCap, and other clinical research management tools, supporting efficient study operations and data management.
COVID MCTO Clinical Trials Supervisor
Icahn School of Medicine at Mount Sinai Hospital
03.2020 - 07.2020
- Manage a team of about 15 Clinical Research Coordinators on 5 clinical trials for treatment of COVID 19
- Train redeployed coordinator staff at Mount Sinai Hospital to run COVID studies at other Mount Sinai sites under MCTO
- Establish a workflow for prescreening potential subjects, picking up and delivering clinical trial drug, collecting laboratory samples, and study data entry
- Facilitated communication between PI's, sponsors, clinical staff, coordinator staff, and laboratory personnel
- Ensure department adhered to GCP, department SOPs, and FDA regulations throughout COVID studies
Certified Clinical Research Coordinator II
Icahn School of Medicine at Mount Sinai Hospital
07.2017 - 03.2020
- Recruit potential patients for clinical trials through preliminary screening
- Explain trial protocols thoroughly to potential subjects and perform screening activities and informed consenting
- Perform study visits including (but not limited to) data collection, vitals, obtaining laboratory samples, Fibroscan procedures, study medication randomization and dispensation, and maintain blinding and unblinding procedures as necessary
- Ensure proper storage and handling of investigational drug and other study supplies
- Collect, report, and follow up with adverse events until resolution has been determined
- Comply with all source document, subject, and study privacy regulations
- Develop study and recruitment/retention plan with PI as well as with recruitment specialist
- Perform site initiation visits, study routine monitoring visits, and close out visits for all studies which listed as a primary coordinator on
Research Assistant
Dr. Ingeborg Dziedzic, MD
08.2011 - 12.2013
- Coordinate study activities for investigator initiated trial
- Review medical records and recruit subjects using practice database
- Create study specific data spreadsheet for use in further initiated studies
- Conduct study visits and carry out study procedures as required
- Collect data through study visits and enter data into EDC system
- Created data reports for investigator to use in final reports of study activities
Education
Bachelors of Science BS - Major in Biological Studies, Minor in Philosophy
Pace University
01.2013
Skills
- Regulatory compliance
- Clinical trial management
- Quality assurance
- Electronic data capture
- Study documentation
- Budget management
Research Certifications And Trainings
- Epic Medical Records
- Medical billing knowledge
- IATA
- RAVE Medidata EDC Essentials
- CITI Research and Staff training
- ECOS Training Completion
- ALMAC IXRS
- CIS EMR System
- EPRO Study Database
- EClinical OS
- Trium CT Engine
- CITI Program and HIPAA training
- CITI Data Security
- Bracket IVRS
- Clinphone
Timeline
Clinical Trials Assistant (part time, contract position)
Clinilabs Pharmaceuticals
05.2022 - 10.2023
Clinical Research Supervisor
Memorial Sloan Kettering Cancer Center
09.2021 - Current
COVID MCTO Clinical Trials Supervisor
Icahn School of Medicine at Mount Sinai Hospital
03.2020 - 07.2020
Clinical Research Manager
Icahn School of Medicine at Mount Sinai Hospital
02.2020 - 09.2021
Certified Clinical Research Coordinator II
Icahn School of Medicine at Mount Sinai Hospital
07.2017 - 03.2020
Research Assistant
Dr. Ingeborg Dziedzic, MD
08.2011 - 12.2013
Bachelors of Science BS - Major in Biological Studies, Minor in Philosophy
Pace University