Danielle (Devlin) Casucci Email & Phone Number

Buffalo, Ny, Us

Buffalo, Ny, Us

Buffalo, Ny, Us

Responsible for the management & oversight of operations as they pertain to clinical research in the area of Neuro-Oncology which involves assisting the CMO/President, CEO & MimiVax, Inc., Board of Directors to continue to operate within the realms of the company's overall mission, values and strategic goals as they pertain to clinical research while assisting to build strong customer relations between those affiliated with various trials, maximizing the company's operational performance across the United States and internationally while the company's research moves forward. This position is well versed in all clinical aspects of all various clinical affiliated with this company while maintaining collaborations with hired CRO(s) and various external sites affiliated across both the Unites States and internationally while also maintaining compliance with Federal wide compliance to clinical research regulations. This position remains innovative with strong leadership and managerial skills and requires maintaining awareness of competitors, expansion opportunities, customers, markets and new industry developments and standards, while continuing to be motivational, goal focused, confident and acquired in the area of public speaking.

Aid in the development and writing of clinical trials, abstracts and Professional Journal Articles in the areas of Glioblastoma, Brain Cancers, Hepatocellular and Advanced Carcinoid Tumors utilizing the latest Pharmaceutical advancements and technologies for leading Neurosurgeons, Special Interest Medical Oncologists and Pathologists in and around the Western New York area. Overseeing the reviews and approvals of these research protocols through the Food and Drug Administration (FDA) and associated Department of Health and Human Services (DHHS) processes and implementation of these research protocols across Cancer Institutes and Hospitals both across the United States and Internationally.

Buffalo, New York, Us

Responsible for creating and building out the Oncology Vertical in community based practices across the United States. This incorporates building strategic plans for clients that focus on awards of oncology trials, relationship building and expansion of oncology based sites and practices along with the generation of leads for the Business Development Team for both clinical trials as well as physician network expansion, managing the performance of the oncology clinical services team through goals and metrics and reporting performance to the executive team, and working collaboratively to conduct oncology site activation while onboarding circuit clinical and physician practice oncology specialists.

Buffalo, Ny, Us

Responsible for the coordination, facilitation and monitoring of RPCI clinical research studies at RPCI and external sites. This position is responsible for study start up activities, site initiation; site monitoring and study close out visits meanwhile tracking data from start to finish to ensure compliance with protocol. The QA coordinator establishes regular lines of communication, relationships and interfaces with external sites across the United States, which include principal investigator, site investigator, managers, clinical research coordinator and designated members of the regulatory and clinical research staff. Provides monitoring support for all facets of RPCI clinical studies with emphasis on institutional (investigator-initiated) studies. Conducts monitoring activities intended to facilitate and assure that the clinical studies comply with the requirements of the approved study protocol, the RPCI Institutional Review Board and applicable Food and Drug Administration (FDA) and other regulatory requirements. Develops risk based monitoring plans. Documents monitoring activities in writing and communicates findings to the appropriate parties. Reviews the accuracy, completeness and timeliness of completed study related records, case report forms and other documents. Reviews study related processes relative to applicable regulatory requirements, including the FDA's ICH-GCP standards and standard operating procedures, as applicable. Maintains in strict confidence all confidential information regarding clinical studies and clinical research study sponsors. Follows RPCI and HIPPA compliance policies.

Buffalo, Ny, Us

Coordinates, facilitates and monitors the implementation of RPCI clinical research studies in the Network within the guidelines of the Code of Federal Regulations, International Conference on Harmonization and Roswell Park Cancer Institute Clinical Research Services (CRS) Standard Operating Procedures; manages and directs study activities and communication between RPCI and sponsors, CROs, investigators and clinical sites (where appropriate) throughout all aspects of a study; assumes responsibility for implementing multiple Network studies simultaneously; interfaces other departments, study sponsors and oncology research cooperative groups and agencies to ensure a collaborative approach to clinical research; keeps a Principal Investigator informed about all aspects of a study; provides education related to clinical research for Network study sites, investigators, CRS staff, other RPCI departments and the public at large; implements processes that ensure compliance with requirements for grants, contracts and other outside funding agencies; participates on various RPCI committees and in professional organizations; promotes and supports RPCI as a Center of Clinical Research Excellence.

Buffalo, Ny, Us

CATHOLIC HEALTH SYSTEM, Buffalo, New York 2001 - 2014Director of Institutional Review Board/Research (2009 - Present)Institutional Review Board Director for system consisting of 4 hospitals and 27 associated off-sites. Responsible for fifteen research coordinators across multidiscipline areas within and outside of the organization. Ensured compliance with the FDA and Department of Health and Human Services. Performed financial analysis and contract review associated with research. Maintained confidentiality in dealing with research, protected patient information and HIPAA regulations. Analyzed and maintained contracts between sponsoring companies, investigators and Catholic Health. Managed Research Coordinators across private physician offices. Facilitated the planning and preparation of the IRB agenda. Attended IRB Meetings. Updated the Research Tracking Log.• Conducted residency training in the area of research design and implementation.• Conducted regular evaluations of CHS IRB and recommends changes as appropriate.• Designed and provided continued IRB and research educational sessions for IRB Chairmen, IRB Members/alternates, research investigators, and counterparts throughout Western New York. • Oversaw the standardization of IRB and research activities and compliance across the CHS.• Created and maintained “Catholic Health System Research Financials and Billing for Investigational Collaborated with Physicians on regulatory devices & pharmaceuticals pertaining to research.• Devices Policy and Procedure”.• Built and maintained strong relationships with Hospital Medical Staff and Administration.

Buffalo, Ny, Us

Achieved and maintained compliance with the Food and Drug Administration and Department of Health and Human Services regarding ongoing research. Shared IRB information, new regulations, and knowledge gained to maintain standardization of IRB processes. Met with IRB support staff and Hospital Administration on IRB activities. Maintained high level of confidentiality in dealing with research and patient information. Ensured that the IRB files were updated in an orderly fashion. Established and maintained an updated Research Tracking Log.• Worked with Chairmen to coordinate IRB Membership and maintained a copy of the Chief Executive Officer’s appointment letters for membership, along with the curriculum vitae of IRB Members.• Achieved the development and implementation of the IRB and Research Policy and Procedure.• Designed and implemented IRB educational sessions for IRB Chairmen, IRB Members and research investigators.

Bachelor'S Of Science (Bs), Bachelor'S Of Arts (Ba), Biology And Psycology

Education record