Director Of Clinical Research
Springfield, Massachusetts Area
De novo build of Department of Clinical Research at a critical access community hospital and integration into regional and national system resources. • Establishment of formal research program in Medical and Radiation Oncology, and outside practices. Program projected to retain 20-30 patients/year. • Singular local management of all aspects of research administration, operations and compliance. De facto local Research Integrity/Compliance Officer. Collaboration with local and regional Corporate Compliance personnel to establish Research Compliance standards. • Highly matrixed reporting responsibilities and collaboration in diverse leadership teams. • Public outreach, resulting in institutional Innovation Award for Medical Oncology and $90k donated to hospital foundation in 1 year. • Personnel management of Investigator, Research Nurse and Coordinator teams, providing training, development and mentorship. • Member of Mercy Medical Center Cancer Committee. Major contributor to obtaining/maintaining accreditation for Sr Caritas Cancer Center, Mercy Breast Care Center, Graduate Medical Education program • Program development and growth strategies to foster collaborative projects between Mercy and St Francis Hospital/Yale-Smilow Cancer Hospital, outside practices, industry sponsors, and others. • Charter member of THoNE Scientific Review Committee, and committee co-liaison to Institutional Review Board. Providing mentorship and support for production of manuscripts, proposals, and regulatory documents. • Technical scientific expertise supporting physicians and recruitment to studies for targeted therapeutics. • Development of formal administrative processes for feasibility reviews, coverage analyses, study budget development, contract negotiations and submissions. • Major contributor to development of Local and Regional/System-Wide policies, procedures and SOPs governing participation in clinical trials.