Michael Oldfield Email & Phone Number

- Oversight of all regulatory affairs conducted at Fox Chase Cancer Center (FCCC), including review committee submissions and completion and maintenance of sponsor regulatory documentation, in conjunction with the Institutional Review Board (IRB), Research Review Committee (RRC), TH-FCCC and non-FCCC Researchers, Contract Office, Industry Sponsors, National Cancer Institute (NCI), NCI National Groups, Clinical Trials Support Unit (CTSU), Food and Drug Administration (FDA), other Academic Centers, and internal departments working in support of clinical trials.- Provide ongoing support to all Researchers and staff to ensure compliance with local and federal regulations and good clinical practice as it applies to all regulatory activity for the conduct of clinical research at TH-FCCC.- Invited to and completed the Temple Health System Management Academy, 2015, and Leadership Academy, 2016.

- Oversaw all therapeutic Investigator-sponsored research conducted at FCCC, including protocol and eCRF development; budget development and analysis; required FDA IND/IDE submissions; maintaining compliance with CT.gov and CTRP requirements; external site selection and activation; maintaining a complete and accurate Trial Master File (TMF); and ensuring that quality data is maintained via local monitoring for publication, DSMB oversight, and FDA review purposes.- Provided ongoing support to all Researchers and staff to ensure compliance with local and federal regulations and good clinical practice specifically for the conduct of TH-FCCC multi-center Investigator-sponsored clinical trials.

- Oversaw all aspects of Clinical Operations, including study coordination and data entry across all tumor types and modalities; utilization of the Forte OnCore and Click Commerce eIRB systems; and liaising with a multitude of external departments, including the infusion area, nursing, hospital staff, diagnostic imaging, pharmacy, etc., in order to properly conduct trials within regulatory and GCP parameters.

- Oversaw all quality affairs for Office of Clinical Research (OCR)-managed trials, including standardized auditing of trials; developing and implementing Department-wide standard operating procedures and other guidance documents; and preparation for and conduct of National Group, Industry Sponsored, and FDA Audits.

- Oversaw all compliance functions for Office of Clinical Research (OCR)-managed trials, including Conflict of Interest identification and resolution; non-compliance identification, investigation, CAPA creation, and reporting as required; and developing and implementing Department-wide standard operating procedures and other guidance documents.

- Oversaw required FDA IND/IDE submissions, compliance with CT.gov and CTRP requirements, and maintenance of a complete and accurate Trial Master File (TMF) for all therapeutic Investigator-sponsored research conducted at FCCC.

- Processed all Phase I, Investigator-Initiated and Compassionate Use regulatory documents for submission to the Pharmaceutical Sponsors, Institutional Review Board (IRB), and FDA, including creating/formatting all consent documents for approval, assisting with protocol development, and preparing FDA IND Reports. - Assisted with coordination of multi-site Investigator Initiated trials, including dissemination and receipt of documents, consent formatting verification, etc. - Main resource for CRU for regulatory issues, including training new CRU and Cancer Center staff. Resource for other CRU stakeholders, including the Oncologists and their support staff, Pharmacy, the IRB, and the Clinical Trials Scientific Review and Monitoring Committee.- Assisted with best practices review and implementation within the CRU.- Reviewed and interpreted pharmaceutical contracts and budgets, including identifying any potential issues.

- Processed all initial regulatory documents for submission to the Pharmaceutical Sponsors and Institutional Review Board (IRB), including formatting all consent documents for approval. Submitted up to approximately 10 studies per month, including Pharmaceutical-sponsored, Cooperative, and External and Internal Investigator-Initiated studies.- Managed the daily operations of the Regulatory Affairs department and staff, including assisting the staff of five on daily duties and any issues, and helming the department in the Director’s absence. Resource for entire CRU staff, as well as other FCCC stakeholders such as the Oncologists and their support staff, Pharmacy, the Protocol Support Lab, the IRB, and the FCCC Research Review Committee.- Processed all management reports for the Clinical Trials Operations office, including HR metrics, accrual compiled in various ways, and the Summaries 3 and 4 Core Grant reports.- Member of the Society of Clinical Research Associates (SoCRA), including Clinical Research Professional certification (CCRP), and member of the department SOP Committee throughout tenure. - Awarded the inaugural institutional Leadership Forum Excellence Award in 2011.

- Processed regulatory documents for submission to the Pharmaceutical Sponsors and Institutional Review Board (IRB), assisted Pharmaceutical Sponsors and Monitors in maintaining required regulatory documents, and cycled through virtually every area/aspect of regulatory affairs.- Member of the Society of Clinical Research Associates (SoCRA), including Clinical Research Professional certification (CCRP).

Jd, Trial Advocacy

Activities and Societies: Student Bar Association, Class VP, 2LE through 4LE Class Assistant, Trial Advocacy Program, Criminal, 4LE

Mba, General

GPA: 3.93

Ba, Marketing