Experience

YCCI, Yale School of Medicine

• United States
• Research
• 1 - 100 Employee

• Regulatory Project Manager

  • Jul 2019 - Present



Yale University School of Medicine

• United States
• Research Services
• 700 & Above Employee

• Grants Coordinator

  • Mar 2017 - Jun 2019



Yale Cancer Ctr

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Regulatory Assistant

  • Jan 2015 - Mar 2017



Rutgers Cancer Institute of New Jersey

• New Brunswick, New Jersey

• Regulatory Affairs Specialist

  • May 2014 - Jan 2015

  -Prepare IRB (Institutional Review Board) initial, amendment, continuing review, and termination submissions; acts as liaison between the Principal Investigator and the IRB to streamline the approval process -Responds to de-briefing memos and provides guidance to Principal Investigators to assist in IRB approvals -Main Regulatory Contact for CINJOG (Cancer Institute of New Jersey Oncology Group) Sites -Site visits to CINJOG/ affiliate sites to orient affiliate research personnel, Sub-Investigators, and Principal Investigators on regulatory requirements, eIRB systems, and affiliation with Rutgers for Citi Training -Regulatory Liaison for Population Science studies providing oversight to assigned program coordinators for IRB submissions, and updates database with affiliate site documents -Submit IND reports to FDA when Principal Investigator is the holder of the IND including FDA 1571 form -Assist Principal Investigator in drafting informed consent forms -Assist Principal Investigator in drafting tumor database / databank SOPs -Obtain all applicable signatures for financial disclosure forms, Statement of Investigator Forms (FDA 1572) -Maintain communication with sites to provide information, track documentation, and progress of clinical trials and adherence to guidelines -Understand and anticipate the needs of the study sponsor’s monitoring and auditing staff; provide accurate, timely, intelligent responses to monitor and/ or sponsor queries regarding regulatory matters -Maintain the status and regulatory documentation (protocols, consent, amendment, investigator brochures) of assigned protocols in OnCore -SRB (Scientific Review Board) Assistant for select meetings to take minutes and provide feedback to Investigators on the Regulatory process -Assist the Regulatory Manager with the development and implementation of administrative policies and procedures that support the efficient coordination of new research protocols from conception through closure and termination Show less



Rutgers University IRB

• Staff Assistant

  • Dec 2012 - May 2014

  -Assist e-IRB conversion process as required -Research Assistance (Pro2012002126 "Assessing Study Non-Completion" – File management, excavating information from New Brunswick, Newark, Stratford databases). -Assist CINJ on projects when requested -Assist Rutgers IRB weekly by generating Notices of Approval and data entry -Responsible for archiving all closed and converted studies -General clerical duties -Front desk duties- phone triage, information requests etc. -Data entry into multiple databases -Responsible for Exempt Study status inventory -Creation and management of reports for Non-Compliance -Generating notices of approvals and closures, and communications to various UMDNJ/ Rutgers researchers -Responsible for organization and maintenance of records -Responsible for meeting minutes, transcriptions, attendance, scheduling and agendas -Assist chairs of IRB Committee as required -Creation and management of spreadsheets -Mailings for Board Meetings Show less