Niveditha Subbiah Email & Phone Number

Chicago, Il, Us

• Manages program operations including planning, program evaluation, policy implementation and proposal development. • In conjunction with CCP committee leadership and study chairs, shepherd concepts through appropriate Alliance review up through NCI approval or disapproval of concept.• Communicates with NCI on Cancer Control Program concepts.• Assure appropriate integration of correlative research aims and their operational execution within Alliance protocols, working closely with the Director of the Translational Research Program Operations.• Facilitate communications and interactions of CCP activities for incorporation into other Alliance scientific committees. • Work closely with the CCP Executive Officer, Alliance Central Protocol Operations and Cancer Care Delivery Program personnel to facilitate protocol development and assist with resolution of relevant operational issues that might arise.• Collaborates with ANF staff, Pharmacy Affairs Manager, and Director of Translational Research Operations. • Work with ANF and Alliance administration to develop budgets for the CCP and NCORP Research Base activities; verify appropriate people and program activities are charged to grant; assists with annual progress report (RPPR) preparations; participate in NCORP research base related meetings and grant submissions.• Coordinate SOP development for the Cancer Control Program.• Promote community provider/staff involvement in all aspects of Alliance scientific and administrative functions.• Serves as a key resource for program information. Resolves problems or questions referred by program staff or other contingencies. • Supervise the work of the Project Coordinator assigned to CCP

Chicago

 Coordinated and provided guidance to the various clinical research oversight committees within DLDCC: Clinical Research Leadership Committee (CRLC); Protocol Review and Monitoring Committee (PRMC); Data Review Committee (DRC); Data and Safety Monitoring Boards (DSMBs).  Coordinated committee activities and meetings, including preparation of the agenda and meeting materials, scheduled meetings, received and routed submissions to the committee members, documented discussions, prepared minutes, and sent correspondence from the committees to investigators.  Maintained accurate records and documentation of protocol oversight activities for over 250 protocols, including correspondence, committee actions, and submitted data. Reviewed and assessed protocols, consent forms and data safety monitoring plans within each protocol submitted to the PRMC for feasibility, clarity, and subject safety. Provided guidance to the committee about the adequacy and suitability of the monitoring plan.  Established and maintained records for implementation of the approved plans, including maintaining a database of DSM reviews for over 60 clinical trials. Assisted with development of standard operating procedures with regard to protocol oversight committees. Coordinated DSMBs for relevant studies, including assisting with DSMB formation, scheduling meetings, collecting and distributing review materials, maintaining correspondence and records.  As Patient Safety Officer, Monitored SAEs (Significant Adverse Events) and unanticipated problems for review by the DLDCC clinical research leadership.  Notified the appropriate oversight committee of SAEs, deviations, and other unanticipated problems.  Notified the clinical research leadership if monitoring plans were not appropriately followed. Provided guidance to investigators in developing an appropriate data safety monitoring plan for investigator-initiated studies including adhering to plan.

New York

 Conducted administrative and regulatory reviews of over 1000 research protocols, informed consent documents, recruitment materials and grant proposals to ensure compliance with Federal regulations on research ethics- 45 CFR 46, Belmont report and institutional policies Conducted human subject research determinations and exempt reviews of protocol submissions Implemented institutional policies on research compliance Educated and coordinated with faculty members and student researchers on protocol submissions and compliance issues Actively assisted researchers with protocol submissions, informed consent and recruitment material preparation from submission through approval Conducted training sessions and workshops throughout Hunter College to promote training and education of researchers, faculty members and graduate students on Ethics and IRB requirements Monitored the progress of expedited reviews and full board reviews by IRB members and Chairs Coordinated IRB meetings, contributed to the discussions and facilitated the review process

Relevant coursework:Clinical ethics, Foundations in bioethics I & II, Clinical ethics rotations, Critical issues in research ethics, Health law, European perspectives on bioethics A comprehensive study of critical issues in research ethics, including the modern history of research ethics in science and medicine, the ethics of clinical trial design and conduct, advanced issues in informed consent, the ethics of animal experimentation, and key issues in genetics research. Discussions of ethical and regulatory frameworks that influence decision-making, policydevelopment, and the conduct of biomedical and social-behavioral science research to explorethe nuances, gaps, challenges, and concerns present in research, particularly research involving human subjects.

Master Of Arts (M.A.), Bio Ethics

L.L.M, Law

L.L.M