Indrawattie Sukhu
Brooklyn,USA
Summary
Experienced Clinical Research and Regulatory Professional with expertise in oncology and pediatric translational medicine. Proven track record in managing regulatory compliance for complex clinical and biospecimen research protocols, navigating FDA and IRB requirements, and mentoring cross-functional teams. Certified Clinical Research Coordinator with GCP and HSP certifications, adept at leveraging advanced clinical systems to optimize regulatory workflows and trial oversight.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Regulatory Research Associate, Department of Pediatrics – Pediatric Translational Medicine
Memorial Sloan Kettering Cancer Center
01.2020 - Current
- Oversee regulatory compliance for 10+ active interventional clinical trials and 5+ biospecimen and retrospective research protocols.
- Coordinate regulatory submissions including IRB submissions, amendments, continuing reviews, and study closures, ensuring compliance with FDA, ICH-GCP, OHRP, and institutional policies.
- Draft, edit, and review study protocols, informed consent forms, investigator brochures, safety reports, and protocol amendments in collaboration with investigators and sponsors.
- Maintain regulatory binders, trial master file (TMF), and electronic systems (eReg, CTMS, PIMS, Protocol Web, MSKCC Tableau Dashboard).
- Support IND and IDE submissions, including FDA-facing documentation, safety reporting, and compliance tracking.
- Serve as liaison between investigators, sponsors, CROs, and internal stakeholders to facilitate timely approvals and resolve regulatory queries.
- Provide training and guidance to research staff and junior associates on regulatory processes, compliance requirements, and institutional standards.
- Participate in inspection readiness, sponsor audits, and FDA inspections to ensure site compliance and quality assurance.
- Prepare, submit and execute Single Patient Use (SPU) Protocol to the IRB and FDA.
Clinical Research Manager, Pulmonary & Critical Care Medicine
Albany Medical Center
01.2017 - 01.2020
- Managed a multi-disciplinary team conducting clinical intervention research trials in sarcoidosis, interstitial pulmonary fibrosis, COPD, and pulmonary arterial hypertension.
- Directed site participation, monitor visits, and ensured all protocol requirements were met.
- Secured an $80k grant for the Pulmonary Clinical Research Department for outstanding work in Sarcoidosis research.
- Provided staff mentorship, training, and leadership development to maximize performance.
- Recognized as Best Study Coordinator in 2018 for BEAT Clinical Trial.
Medical Assistant/Office Manager
Long Island Health Associates
01.2014 - 01.2016
Medical Director
Drew Hamilton Community Center
01.2013 - 01.2014
Medical Technologist
Harlem Center Nursing Home
01.2012 - 01.2013
Biology Teacher & Counselor
Hobart & William Smith College
01.2009 - 01.2012
Emergency Medical Technician
NYS EMS
01.2004 - 01.2008
Education
D.O., Doctor of Osteopathic Medicine -
Touro College of Osteopathic Medicine
New York01.2014
M.S. - Interdisciplinary Studies in Biological & Physical Sciences
Touro College of Osteopathic Medicine
New York, NY01.2010
B.S. - Biology (Minor: Global Public Health)
Bard College
Poughkeepsie, NY01.2008
Skills
- Regulatory Submissions (FDA, IRB, ICH-GCP)
- Protocol Compliance & Quality Assurance
- IND/IDE Support & Safety Reporting
- Oncology & Pediatric Translational Medicine Trials
- Single Patient Use Trials
- Clinical Trial Management Systems (CTMS, PIMS, Protocol Web)
- Audit & Inspection Readiness
- EPIC EMR & MSKCC Tableau Dashboard
- WIRB Connexus
- CRM Tracking/ Project management
- Grant writing
- Protocol development
- Experimental design/ research planning
- Data Analysis & Scientific Writing
- Qualitative and quantitative research
- Progress reporting
- Research methodology
- Questionnaire building
- Participant screening/ recruitment
- Source verification
- Telephone surveying
- Phlebotomy
- Specimen processing
- Inventory assessments/ reviews
- Data collection and organization
- Research presentation
- Strong work ethic
- Team collaboration
- Staff Training & Leadership
Certification
- Certified Clinical Research Coordinator (CCRC)
- Good Clinical Practice (GCP) Certification
- Human Subjects Protection (HSP) Certification
Publications
- Judson M., Sukhu I., et al. The Assessment of Cough in a Sarcoidosis Clinic Using a Validated Instrument and a Visual Analog Scale. LUNG Medical Journal, 2017.
- Judson M., Sukhu I., et al. Quantifying the Relationship Between Symptoms at Presentation and the Prognosis of Sarcoidosis. Respiratory Medicine Journal, 2019.
- Medarov B., Sukhu I., et al. Assessing the Reliability of Obstructive Sleep Apnea Screening Instruments. Journal of Sleep Medicine.
- SOCRA Annual Conference, Orlando, FL, 2017
- OPUS Registry Study Coordinator Meeting, Dallas, TX, 2016
- Investigator Meeting, Washington D.C., 2017
Timeline
Regulatory Research Associate, Department of Pediatrics – Pediatric Translational Medicine
Memorial Sloan Kettering Cancer Center
01.2020 - Current
Clinical Research Manager, Pulmonary & Critical Care Medicine
Albany Medical Center
01.2017 - 01.2020
Medical Assistant/Office Manager
Long Island Health Associates
01.2014 - 01.2016
Medical Director
Drew Hamilton Community Center
01.2013 - 01.2014
Medical Technologist
Harlem Center Nursing Home
01.2012 - 01.2013
Biology Teacher & Counselor
Hobart & William Smith College
01.2009 - 01.2012
Emergency Medical Technician
NYS EMS
01.2004 - 01.2008
D.O., Doctor of Osteopathic Medicine -
Touro College of Osteopathic Medicine
M.S. - Interdisciplinary Studies in Biological & Physical Sciences
Touro College of Osteopathic Medicine
B.S. - Biology (Minor: Global Public Health)
Bard College
Similar Profiles
Yohannes Abere AmbawYohannes Abere Ambaw
POSTDOCTORAL RESEARCH ASSOCIATE at Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute, Cell Biology DepartmentPOSTDOCTORAL RESEARCH ASSOCIATE at Memorial Sloan Kettering Cancer Center, Sloan Kettering Institute, Cell Biology Department
NICOLE ALLARDNICOLE ALLARD
Site Supervisor at New York Cancer & Blood Specialist (Affiliated with Memorial Sloan Kettering Cancer Center)Site Supervisor at New York Cancer & Blood Specialist (Affiliated with Memorial Sloan Kettering Cancer Center)
Nelson DejesusNelson Dejesus
Guest Service Representative/Concierge at Memorial Sloan Kettering Cancer Center Josie Robertson Surgery CenterGuest Service Representative/Concierge at Memorial Sloan Kettering Cancer Center Josie Robertson Surgery Center
Hrisula DervishiHrisula Dervishi
TEAM LEAD, Outpatient & Hospital Operations at Memorial Sloan Kettering Cancer Center – Evelyn H. Lauder Breast CenterTEAM LEAD, Outpatient & Hospital Operations at Memorial Sloan Kettering Cancer Center – Evelyn H. Lauder Breast Center
VERNIQUE FRANCISVERNIQUE FRANCIS
Human Resource Generalist at Pay O Matic CorporationHuman Resource Generalist at Pay O Matic Corporation