Supervisor, Data Safety & Monitoring Office
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 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 nationâ€™s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Supervisor, Data Safety & Monitoring Office
The Supervisor, Data Safety & Monitoring Office provides administrative and operational oversight for the City of Hopeâ€™s Data and Safety Monitoring Committee (DSMC). The Supervisor ensures compliance with all external regulations, best practices and internal policies. Through close collaboration with the Director for Safety and Data Quality, as well as the DSMC Committee chairs, the Supervisor provides an efficient and effective operating framework to ensure the timely review of data safety monitoring plans and the ongoing safety and data quality of human subject research at City of Hope.
The Supervisor is expected to collaborate closely with the Office of Clinical Trials Auditing and Monitoring (OCTAM) to ensure that institutional policies in regards to protocol conduct are followed; with the leadership of the Clinical Trials Offices to provide guidance and training to the clinical trials staff; and with the administrative staff of the other regulatory committees in Clinical Research Protections (CRP) and Laboratory Research Protections (LRP) to maintain compliance and reduce time to study startup.
- Supervise 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 performance evaluations on their ability to document meeting activity and record meeting minutes. Work with the Director, Safety and Data Quality to benchmark workload volumes against staffing needs.
- Responsible for the review for completeness and timely processing of all submissions, including new protocols, amendments, adverse event/unanticipated problem (AE/UP) reports, and Protocol Management Team (PMT) reports. Regularly review submission application forms, training materials/guidance documents, templates and checklists to identify opportunities for process improvements. Monitor and take steps to ensure compliance with PMT reporting requirements, working with the Director, Safety & Data Quality, investigators, DSMC and IRB to address noncompliance with data safety monitoring plan and PMT reporting requirements.
- Responsible for the organization and timely distribution of review materials to the DSMC. Work with committee members and DSMC analysts to ensure efficient and effective meeting conduct, and accurate meeting minutes. Ensure that Committee Action Notices to investigators are issued in a timely fashion. Assures that committee responses are reviewed by committee members in a timely fashion.
- Working with the Director, Safety and Data Quality, and other leaders within Research Protections and Safety & Data Quality, maintains and revises the City of Hope Data and Safety Monitoring Plan (Institutional DSMP) to ensure alignment to the NCI requirements, as well as maintains the DSMC charter and policies and procedures. Responsible for ensuring that protocol specific DSM templates are consistent with the Institutional DSMP and are appropriate to the protocol risk level. Assures that all relevant information is communicated to committee chairpersons, principal investigators, the IRB, CTO, and other relevant groups.
- Develop and deliver training on committee review procedures and submission requirements for various members of the COH clinical research community.
- Working with the Director, Safety and Data Quality, 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.
- Working with the Director, Safety and Data Quality, regularly assess DSMC practices for alignment with federal and state and local regulations, accreditation standards, NIH and CCSG requirements and best practices related to data safety and monitoring. Working knowledge of GCP, Code of Federal Regulations. Participates in ongoing clinical research performance improvement initiatives. Keep abreast of new internal and external developments related to clinical research scientific and safety review
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
The following Pillars in Action are the behaviors that accelerate our impact as we deliver on our Vision and Strategic Priorities:
SPEED. We move with speed.
- We execute with a sense of urgency.
- We learn quickly and adjust course.
- We take ownership and eliminate bottlenecks and barriers.
FOCUS. We act with discipline and focus.
- We own City of Hopeâ€™s enterprise priorities.
- We deliver measurable results.
- We explore ideas broadly, and commit to ideas selectively.
ENTERPRISE. We behave as one enterprise.
- We work together, not in silos.
- We stand by each other and our decisions.
- We encourage innovative thinking and embrace responsible risk taking.
CONNECTEDNESS. We connect and network.
- We attract and collaborate with diverse talent.
- We connect and extend our relationships.
- We welcome and embrace external partners.
SPONSORSHIP. We trust and sponsor.
- We value and inspire each other.
- We extend trust.
- We sponsor each otherâ€™s success.
The position directly supervises:
- DSMC Research Protocol Analysts
The position indirectly supervises:
- Bachelor's Degree required; relevant work experience in lieu of degree is acceptable.
- Eight or more years of experience in clinical research conduct, administration and / or management, preferably in a NCI-designated Comprehensive Cancer Center or academic medical center. Plus 1-2 years of experience in a supervisory/managerial capacity.
- Masterâ€™s Degree preferred.
- CRC or CRA certification
- Demonstrated ability to work with clinicians and scientists, preferably in an academic environment
- Must be familiar with the NCI guidelines for Data and Safety Monitoring (DSM). This role is a critical component of the Cancer Center Support Grant. Failure to comply with NCI and / or government regulations could jeopardize the Cancer Center Core Grant (CCSG) and potentially result in a suspension of human subjectâ€™s research and a loss of government funding.
- Knowledge of NCI site visit protocols and documentation requirements. During NCI grant reviews and site visits, CPDM operations, including SOPs, internal procedures, and files are closely reviewed.
- 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.
City of Hope is committed to creating a diverse environment and is proud to be 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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