Manage the operations of Mary Crowley Cancer Research (MCCR) Regulatory Department to ensure compliance with governmental regulations, guidelines, and industry standards. Direct activities as they relate to clinical trials in the areas of study development and department operations in regulatory / safety. Provide this support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines and Mary Crowley Standard Operating Procedures (SOPs).
Develop and implement departmental goals that align with MCCR’s vision and business goals. Cascade goals down to individual staff’s annual objectives.
Oversee the activities of the Regulatory Department including all tasks associated with the overarching regulatory oversight and management of MCCR’s trial portfolio.
Coach, mentor, and develop the Regulatory team.
Provide ongoing education on the regulatory aspects of research conduct to all staff.
Liaise between local and commercial Institutional Review Boards (IRB), Institutional Biosafety Committee (IBC), regulatory agencies, and other applicable groups
Manage the applications, safety events, and reports to applicable regulatory agencies and direct requests for information from regulatory agencies
Accountable for regulatory compliance and audit readiness by verifying investigator site binders are up-to-date and complete
Operate as institutional expert on regulations; assure compliance with governmental regulations, guidelines and industry standards.
Monitor new and revised regulations and lead in the evaluation and implementation of standards and requirements for operations
Contribute to and support the development and maintenance of clinical research processes, standard operating procedures (SOPs), and training manuals; ensure regular updates.
Oversee the development of clinical trial implementation and management processes and tools (i.e. clinical trial management spreadsheets, critical document collection, safety reporting, Institutional Review Board (IRB) submission process) in consideration of pharmaceutical company (Sponsor) and/or contract research organization (CRO) processes and requirements, in addition to Mary Crowley processes.
Collaborate with team members to recognize and implement quality improvement programs and initiatives, with a specific focus on regulatory Compliance.
Collaborate with and support Principal Investigator (PIs) in understanding the investigator commitments; conduct regular meetings with PI for oversight.
Minimum of a Bachelor’s Degree in a clinical or scientific related discipline and a minimum of 6 years related experience in clinical research and/or an oncology related field. An equivalent combination of education and experience, which provides proficiency in the areas of responsibility, may be substituted for the education and experience requirements.
Knowledge of management practices and operations.
Proficient in Microsoft Office including MS Word, Excel, Access and PowerPoint; MS Outlook and Internet Explorer.
Clinical Research Professional Certification, preferred
Mary Crowley Cancer Research is a specialized clinical research center that offers access to new investigational therapies through the administration of Phase I and II clinical trials. Our approach is to rapidly advance the discovery of potential new therapies and positively impact the care of cancer patients in their lifetime.