Manager, Data Safety & Monitoring Office
The Manager, Data Safety & Monitoring Office provides administrative and operational oversight for the City of Hope’s Data and Safety Monitoring Committee (DSMC). Work collaboratively with the Director for Clinical Research Protections as well as the manager for the PSRMO OHRSP, Directors and Managers within Research Operations and other institutional leaders to evaluate and remediate compliance issues, Corporate Compliance and the Associate Director for Administration of the Cancer Center Support Grant. The Manager ensures compliance with all external regulations, best practices and internal policies. Through close collaboration with the committee’s physician leaders and members, the Manager provides an efficient and effective operating framework for the safety review committee.
Key Responsibilities include:
- Manage day to day operations of the DSMC, proactively identifying and implementing solutions to improve efficiency, effectiveness, and timeliness of office procedures. Supervise and provide direction for DSMC analysts including hiring and performance evaluations on their ability to document meeting activity and record meeting minutes.
- Authors and revises the DSMC charter and policies and procedures as needed. Lead efforts to improve compliance with policies and procedures. Assures that all relevant information is communicated to committee chairpersons, principal investigators, the IRB, CTO, and other relevant groups. Coordinates regularly with the IRB and other leaders within the Office of Clinical Research Operations.
- Oversee review of the Data and Safety Monitoring Plan in new protocols and in amendments, adverse event/unanticipated problem (AE/UP) reports, and Protocol Management Team (PMT) reports for completeness and correctness. Monitor and enforce compliance with PMT reporting requirements, working with investigators and the IRB to address noncompliance with data safety monitoring plans.
- Oversee the organization and distribution of review materials via paper and/or electronic mediums to committee members. Organize, facilitate and attend all committee meetings. Work with committee members and subordinate staff to ensure efficient and effective meeting conduct, and accurate meeting minutes. After each committee meeting, ensure that action notices are completed and signed, meeting minutes are prepared and distributed, and follow-up items are completed and tracked. Co-authors committee responses to investigators. Assures that committee responses are reviewed, signed by the Chairperson, and communicated promptly to the investigator and to other committees / stakeholders as necessary
- Develop and deliver training on committee review procedures and submission requirements for various members of the COH clinical research community.
- Use established metrics, and participate in the development of new metrics to monitor investigator compliance with DSMC-required processes and investigator/administrator error rates, and identify modifications to training and communication activities as well as policies and procedures to address these deficiencies as part of ongoing quality improvement effort. Use quantitative and qualitative metrics, along with various forms of stakeholder feedback, to identify performance improvement opportunities and implement process improvements.
- Assess DSMC practices for alignment with federal and state and local regulations, accreditation standards, and best practices related to data safety and monitoring. Working knowledge of GCP, Federal Regulations and guidance on the review and monitoring of human subject research. Participates in ongoing clinical research performance improvement initiatives. Keep abreast of new internal and external developments related to clinical research scientific and safety review
- The position directly supervises two protocol analysts
Minimum Education and Skills Required for Consideration:
- Bachelor’s Degree.
- 5+ years of experience in clinical research conduct, administration and / or management, preferably in a NCI-designated Cancer Center or academic medical center.
- Must be familiar with the NCI guidelines for Cancer Center Data and Safety Monitoring (DSM).
- Knowledge of NCI site visit protocols and documentation requirements. During NCI grant reviews and site visits, data and safety monitoring operations, including SOPs, internal procedures, and files are closely reviewed.
Preferred skills and experience:
- Master’s Degree preferred.
- Demonstrated ability to work with clinicians and scientists, preferably in an academic environment
- Demonstrated leadership, process improvement, personnel management and problem solving skills.
- Working knowledge of Good Clinical Practice (GCP) standards and clinical research regulatory requirements from the FDA, NIH, IRBs, and study sponsors.
- Excellent oral and written communication skills.
- Outstanding customer service orientation.
About City of Hope:
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
City of Hope strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced. City of Hope is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
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