Research Regulatory and Compliance Manager / February, 2023 — Present

• Responsibility for compiling regulatory submissions to the NCATS, IRB, either local or central agencies. • Ability to effectively problem solve within a cross-functional team • Ensure that all federal regulatory requirements are addressed for the clinical research projects. • Familiarity with Human Subjects Research Regulations; and Institutional Processes. • Oversees the process, and provides assistance and guidance in the submission documents for the NCATS Prior Approval e.g.: changes in key personnel, addition of a foreign component and request to carryover funds • Lead the KL2 Scholar Projects and certain Pilot Projects that include human subjects research requiring formal Prior Approval • To facilitate consistency, efficiency, and enhance the submission of successful CTSA-related information packages to NCATS • Review and improve UL1- and KL2-related administrative interactions with NCATS • Obtain training from NCATS and other CTSA Consortium members and train others at the institution • Interact with a QA/QC group (to be created); attend quarterly virtual meetings; participate in a virtual QA/QC Discussion Forum • Propose improvements/innovations • Develop professional relationships with IRB and Grants office staff. • Provide regulatory expertise to research project teams • Manage the final product submissions and negotiate and communicate effectively with regulatory authorities and sponsor representatives to obtain timely project and protocol approvals. • Recognize recurring issues and analyze their causes in order to reach a solution. • Identify compliance issues that require follow-up or investigation. • Verify that all regulatory policies and procedures have been documented, implemented, and communicated. • Other related duties as assigned by the Director

Research Platform Specialist (Consultant) / July, 2022 — Present

• Responsible for providing insight in to processes and various stages of clinical trials • Improve user experience for institutions using our study platform • Provide regulatory guidance to the engineering team on various projects like cancer and long COVID research platforms • Attend meetings academic institutions to design the website platform that is engaging for patients and study teams • Consult about various methods to improve recruitment for clinical trials and maximize subject retention • Attend meetings with various stakeholders and patient advocacy groups from different institutions

Clinical Research Program Manager Cooperative Group, ETCTN, Pediatric Oncology (Temp) / April, 2022 — July, 2022

Responsible for the day-to-day management of the clinical research and related activities for specified programs and/or disease area(s) •Serves as central point person for program related matters and issues •Provides guidance on research-related questions within the program •Troubleshoots potential issues and facilitates smooth clinical study operations among research team •Recruits, trains, and supervises study coordinators and research assistants to ensure efficient and effective operations •Responsible for the operational oversight of all clinical research studies within the program area to ensure compliance with regulations, SOPs, and protocol •Assists the Assistant Director with tracking and prioritization of research portfolio •Manages logistical and operational issues related to study start up and closeout, including non-regulatory related submissions •In collaboration with the Assistant Director, conducts workload assessments to determine staffing levels •Oversees data timeliness and quality •Performs QA reviews in EDC and subject research records, including OnCore •Ensures compliance with internal/external audits, inspections and monitoring reports •Assists with development and implementation of corrective action plans to address deficiencies as necessary •May serve as liaison to audit team(s) during on-site visits •Oversees reconciliation of research charges, invoiceables, and subject financial trackers for assigned services •Responsible for dissemination of research-related billing information and policies to clinical trials staff and investigator •Performs other job related duties as required

Clinical Research Coordinator (Mostly Regulatory with Some Patient-Facing Responsibilities) / October, 2001 — April, 2022

• Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and monitoring while the subjects are on study. Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports. • Supports enrolling patients onto the clinical trial through screening, enrollment and follow up of eligible subjects according to protocol requirements. • Ensures the protection of study patients by verifying informed consent procedures and adheres to study protocol requirements/compliance. • Collects, completes, and enters data into study specific case report forms or electronic data capture systems. Ensures timely and accurate data completion. • Collects blood samples and tracks shipments and requests supplies as needed. • Implements Study-specific communications. • Ensures timely adherence to protocol requirements. • Responsible for completion of all required documentation. • Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, subject logs and study-related communications. • Communicates all study-related issues to appropriate study colleagues or manager. • Attends study specific meetings as required or asked to do so. • Reviews and responds to any monitoring findings and escalates issues. • Computer skills with demonstrated abilities using web-based applications, electronic data capture, and MS Word or Excel. • Maintain and implement the duties and obligations required for securing and protecting from disclosure confidentiality and proprietary information, including personal identifiable information (PII) and patient health information (PHI) of the Institution and of the Study at all times. Compliance at all times with all Institution’s Policies, Standard Operating Procedures, rules, and, directives.

Sr. Clinical Trials Coordinator / February, 2018 — October, 2021

Regulatory Responsibilities: • Coordinating all aspects of Phase I-Phase IV clinical trials. • Developing protocols and submissions to regulatory and funding authorities. • Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs. • Escort CRAs/government inspectors during monitoring and provide post-monitoring follow-up information as requested. • Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation. • Evaluating protocols and budgets for operational and fiscal feasibility. • Initiation and start-up of clinical trials and observational studies, including development of SOPs and case report forms. • Submission of IRB protocols, renewals, and modifications. • Patient-Facing Responsibilities: • Play an integral role in the coordination and conduct of clinical trials at the ALS Center providing support in guiding, shaping, and executing neuromuscular research initiatives. • Responsible for providing direction and supervision of research operations and staff. • Adherence to federal and institutional regulations and GCP guidelines. • Subject recruitment and coordination of the study visit activities, including informed consent, screening, breathing and muscle tests, cognitive testing, infusions, and lumbar punctures. • Collection, processing, and shipping of biological specimens according to IATA standards. • Data management, collection of source documents, maintaining regulatory binders, drug accountability logs and documentation and management of AEs and SAEs for monitoring visits. • Support weekly ALS clinic in functional rating assessments and respiratory function tests.

Clinical Research Coordinator/Clinical Rater / May, 2017 — January, 2018

• Performing initial psychiatric evaluations and intakes for patients with depression, anxiety, PTSD, chronic pain disorders and neurological disorders. • Administering structured and semi structured rating scales; SIGMA MADRS, CSSRS, SCID, CAPS-5, HAM-D, LSAS, CADDS. • Primary research coordinator for the IV Rapastinel trial and co-coordinator for intranasal ketamine trial. • Phlebotomy and ECG. • Coordinating patients enrolled in studies, scheduling patient visits. • Screening patients and completing full study visits. • Reporting SAE’s, AE’s, Protocol Deviations. • Knowledge of GCP and FDA code of Federal Regulations, Guidance for Clinical Trials. • Assisting with regulatory documents, preparing charts for monitoring visit, checking for completeness and accuracy for charts and eCRF’s. • Assisting physicians with completing study visit procedures and following up with patients.

Research Coordinator and Research Assistant / August, 2012 — September, 2016

• Screening EPIC (WCM), Allscripts, Cath Lab and CT Surgery lists to recruit patients for the R01 protocol “Cardiac MRI and Echocardiography for Mitral Regurgitation”. • Enrolling, consenting and coordinating patients for “Cardiac MRI and Echocardiography for Mitral Regurgitation” protocol. • Ensuring follow up visits for patients and maintaining databases. • Entering data into EDC. • Coordinate studies from other hospitals including Memorial Sloan Kettering and NYP Columbia. • Writing, amending and renewing IRB protocols. • Data analysis using SPSS and Excel. • Billing for patients and other administrative work. • Supervise RA’s.• Work in collaboration with Brain Trauma Foundation to recruit and screen mTBI patients from the emergency room at NewYork-Presbyterian, Weill Cornell for the DoD funded EYE-TRAC Advance research study. • Train new research assistants on various projects. • Perform neurocognitive battery once subjects are enrolled. The subject population was mainly pediatric, adolescent and young adult. • Assist Principal Investigator with implementation of DARPA funded research project in the Department of Pediatric neurology. • Obtain consents from participants and patients in various clinical research studies. • Direct and oversee autism clinical research database, Batten’s database and all other relevant clinical research databases. • Perform statistical analysis such as ANOVAs, generalized linear/mixed models and regression analysis on various projects using SPSS. • Manage and assist with IRB protocols for clinical and animal research. • Present data in lab meeting as requested. • Participate in lab journal club, and other didactic activities. • Organize telephone conference, web conferences and meetings with our collaborators. • Assist with manuscript editing, writing and performing statistical analysis.• Assist the Principal Investigator with implementation of federally-funded research project in the Department of Psychiatry. The goal of the study was to develop a psychosocial intervention for older adults with the diagnosis of anxiety following an injury from a fall. • Perform hospital bed-side consenting and administering standardized clinical scales; MMSE, Modified Fall Efficacy Scale, CAM, CAPS, HADS and ASD. • Recruit patients from Acute Care for the Elderly and Surgical Intensive Care Unit at NewYork-Presbyterian, Weill Cornell, schedule study appointments for research subjects by phone and track subjects visits over time for follow-up assessments. • Assist with coordination of study with faculty in other departments • Assist in preparation of required research documentations including IRB protocols. • Develop and prepare data collection sheets. • Assist with the analysis of data from performance of computerized tasks. • Review data for accuracy and maintain records of study data. • Assist in literature review and preparation of presentations and publications. • Publication acknowledged in: http://www.tandfonline.com/doi/abs/10.1080/01621424.2013.813885#.UuvYEBBdUfU