NYU Langone Health

- Collaborates with Reliance Specialist to evaluate requests for Single IRB (sIRB) pre-grant application and other IRB's reliance pre-grant application for accuracy, completeness, and adherence to IRB SOPs, OHRP, and Federal Regulations. Reviews all participating site submissions, including Expedited and Full 

- Board continuations, modifications, and responses, when necessary, as the SIRB, in advance
Performs External IRB/Administrative review and clearance of studies that rely on External IRB for review, comprising initial submissions, continuations, and modifications

- Provides guidance and support to study teams throughout the IRB review process, answering questions and addressing concerns as needed

- Manages a team of IRB analysts, providing training and mentorship to ensure that they can perform their duties effectively

- Facilitates communication between the IRB and study teams, ensuring that all parties are informed of the status of their submissions and any decisions or requirements

- Considers community and partners for sIRB and external IRBs, suggest improvements for efficiency, and aids the Assistant Director with projects and protocol-specific issues

- Executes assigned duties while remaining a friendly and efficient research community partner

Senior Analyst-External Review Unit

- Reviewed expedited continuation and amendment submissions before approval
- Examined protocols, consent forms, and other relevant documents for compliance with regulations and guidelines
- Verified that all documentation met IRB policies, procedures, and federal regulations
- Analyzed and interpreted electronic medical records (EMRs) to identify patient data for expedited reporting to regulatory agencies
- Communicated effectively with healthcare providers to obtain missing information necessary for expedited reporting
- Collaborated with cross-functional teams, including physicians, nurses, and pharmacists, to ensure accurate and timely reporting of adverse events
- Conducted regular follow-ups with PIs and the local study team on all outstanding issues resulting from pre-review correspondence
- Developed and maintained databases and tracking tools to monitor and report adverse events

Expedited Analyst-Human Research Protection

- Coordinated the NIH Ischemia Study by collaborating with the patient care team to recruit eligible research subjects, obtain consent forms, extract medical information, and review data
- Managed and coordinated multiple clinical research studies focused on cardiovascular diseases, including recruitment, scheduling, and tracking of study participants
- Developed and maintained study protocols, informed consent forms, and other study-related documentation by regulatory guidelines
- Conducted data collection and analysis, including patient assessments, laboratory measurements, and electronic health record reviews, using various software tools and databases
- Trained and supervised research assistants and volunteers on study procedures and regulations
- Assisted in manuscript preparation and submission, including data interpretation and figure creation

Research Coordinator

Data Research Associate – Transplant		Dec’09-Dec’14
Research Coordinator – Transplant  		Jan’15 - present

- Conducted literature reviews and synthesized information to support research projects
- Collaborated with the research team to design and implement clinical research studies
- Coordinated and oversaw study visits, including obtaining informed consent and administering study procedures
- Acquired and retained knowledge of protocol requirements for patient visits, test procedures, and drug accountability to ensure compliance
- Oversaw Phase 2 and 3 clinical data from site selection to study closure, managing tasks such as patient recruitment and EDC management
- Recruited research subjects, verified eligibility, obtained consent, extracted medical information, and reviewed data
- Ensured regulatory compliance by completing IRB submissions for amendments, continuation, reportable events, and study closures
- Created and maintained databases for research studies using software such as REDCap and Excel
- Cleaned, validated, and analyzed study data using statistical software such as SPSS and SAS
- Produced charts, tables, and graphs to summarize and present study findings
- Represented NYU Transplant Department by attending Investigator/Study Coordinator meetings as needed
- Performed inventory control of all supplies including CRFs, specimen kits, and other related study supplies

SUNY Downstate Medical Center

- Communicate with patients to confirm appointments, maintain patient appointments, schedule research follow-ups, and complete regulatory forms such as transplant appointment demographic forms.
- Performed administrative duties such as medical document requests from the dialysis center unit.

Staff Assistant/Administrative Assistant

- Maintained financial paperwork including purchase & personal requisitions, travel approval & travel vouchers for faculty & medical school students in the department database
- Maintained health care provider files and credentialing, including DEA, medical license, board certification, infection control, and NYS registration.
- Managed inventory control. Created and maintained detailed records of all requisitions for supplies.

Administrative Assistant

The Endorser| Experienced Administrative Assistant | IRB Coordinator with Proven Track Record of Delivering High-Quality Results

As a focused, self-motivated, and experienced Administrative Assistant/ Research Associate, I am dedicated to providing top-notch support to teams and executives. I possess strong organizational skills, attention to detail, and exceptional communication abilities, which enable me to handle multiple tasks simultaneously. With a background in research, I have a proven track record of delivering accurate and timely results. Additionally, I am proficient in various software and project management tools that make me an efficient team player. Overall, I am a dependable and proactive individual committed to achieving organizational goals while maintaining high standards of professionalism.

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