Karishma Sookraj
Kew Gardens,NY
Summary
Clinical Research Associate with over five years of experience managing and overseeing early-phase and late-phase pediatric oncology clinical trials at Columbia University Medical Center (CUIMC). Experienced in leading cross-functional teams, driving audit readiness, and optimizing site performance.
Overview
5
5
years of professional experience
Work History
Children’s Oncology Group (COG) Lead Clinical Research Associate (CRA)
Columbia University Medical Center
10.2023 - Current
- Ensure protocol and regulatory compliance across all Phase II/III COG trials (FDA, NCI, GCP, IRB).
- Improve institutional performance by resolving data queries and reducing delinquent forms.
- Manage COG institutional roster and support credentialing through CTSU/CTEP-IAM and RCR.
- Coordinate COG and PEP-CTN audits and lead follow-up actions, including CAPA implementation.
- Conduct quarterly reviews with the PI to assess data submission timelines and drive corrective actions.
- Perform quality checks on consenting, eligibility and enrollment data to ensure full protocol compliance.
- Disseminate COG communications and produce the division’s quarterly clinical trials newsletter.
Clinical Research Coordinator I
Columbia University Medical Center
07.2023 - Current
- Lead Phase I/II industry-sponsored trials for the Pediatric Cancer Foundation Developmental Therapeutics Program (PCFDTP) and Neuro-Oncology Program.
- Oversee a team of seven, ensuring site readiness, regulatory compliance, and audit preparedness.
- Partner with Investigational Drug Services to verify investigational product accountability and compliance.
- Maintain timely, accurate data entry across Velos, IBM CTMS, Epic, and Medidata to support enrollment, budgeting, and safety monitoring.
- Provide weekly study status updates and patient progress summaries to investigators and leadership.
- Lead onboarding and training for new staff on SOPs, workflows, and best practices.
Clinical Research Coordinator
Columbia University Medical Center
03.2022 - 07.2023
- Coordinated daily activities for early-phase PEP-CTN, TACL, investigator-initiated, and industry-sponsored trials.
- Supported informed consent, enrollment, and adherence to ethical and regulatory standards.
- Scheduled and coordinated clinical procedures and ensured completion of outstanding research tasks.
- Managed patient enrollment/randomization through OPEN and Cenduit IRT systems.
- Communicated trial updates at investigator meetings and supported initiation visits.
- Organized monitoring visits and prepared source documentation and IRB materials.
- Assisted with regulatory submissions, including amendments, continuing reviews, and safety reports.
Program Outreach Assistant
Columbia University Medical Center
12.2020 - 03.2022
- Supported grant-funded HIV and COVID-19 prevention studies, including participant screening and eligibility assessments.
- Scheduled study visits across mobile units, field sites, and clinics, ensuring participant adherence.
- Entered study data into REDCap and Medidata and maintained accurate source documentation.
- Coordinated specimen collection and transport and ensured timely delivery of study drugs.
- Implemented quality improvement processes to support data integrity and participant retention.
Education
Master of Public Health -
Adelphi University
Garden City12.2021
Bachelor of Science -
CUNY, York College
Jamaica12.2017
Timeline
Children’s Oncology Group (COG) Lead Clinical Research Associate (CRA)
Columbia University Medical Center
10.2023 - Current
Clinical Research Coordinator I
Columbia University Medical Center
07.2023 - Current
Clinical Research Coordinator
Columbia University Medical Center
03.2022 - 07.2023
Program Outreach Assistant
Columbia University Medical Center
12.2020 - 03.2022
Master of Public Health -
Adelphi University
Bachelor of Science -
CUNY, York College