Senior Manager, Multicenter Research Operations
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.
Senior Manager, Multicenter Research Operations
The Senior Manager for Multicenter Research Operations provides consistent leadership as well as operational and general oversight of City of Hopeâ€™s Multicenter Research to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. The Senior Manager supervises, monitors and supports the timely study start up, administration and progress of City of Hope led clinical research conducted at multiple institutions.
The Multicenter Research Operations team is responsible for monitoring and developing strategies to meet the timelines/milestones of the assigned clinical studies as well as working with COH PIs to ensuring that study personnel at study sites receive appropriate training to conduct COH studies according to the approved protocol, current Good Clinical Practices governing clinical research, and all applicable regulatory requirements. The Multicenter Research Operations is expected to work with others in research operations to respond to anticipate growth in Multicenter research activities and support the research operation strategic priorities to enhance interdepartmental communication and collaboration by supporting the implementation of best practices and tools for protocol execution, management and oversight as well as ensure, protocol compliance, quality data collection and compliance with Service Level Agreements (SLAs).
The Senior Manager is expected to collaborate closely with the Director of Safety and Data Quality in developing standard procedures, tools and systems, as well as tracking metrics. They will also provide assistance to Office of IND Development and Regulatory Affairs (OIDRA) for studies with COH INDs with providing information about the sites, and reported AEs, SAEs, or UPs and any regulatory documents that are needed for the FDA. The leadership team in the Clinical Trials Office (CTO) will work with the Senior Manager to develop guidelines and tools to assist in protocol compliance and data collection. The Senior Manager is expected to collaborate closely with other managers and directors throughout Research Operations and City of Hope including the Office of Clinical Trials Auditing and Monitoring (OCTAM) to ensure outside sites are minimally meeting City of Hope expectations; Clinical Trial Support Services (CTSS) to provide appropriate guidance on budgets and contracts upon request and as needed; OIDRA; Research Compliance; Office of Clinical Protocol Development (OCPD) to develop templates that adequately support the outside sites; forms developers to assist in the development of appropriate Electronic Data Capture (EDC); and others.
- Leads the day to day operations of the Multicenter Research Operations team in proactively identifying and implementing solutions to improve efficiency, effectiveness, and timeliness of the activation of COH studies at outside sites, as well as study compliance through effective and robust study monitoring. Supervises and provides direction for the Multicenter Coordinators (MCCs) including hiring and performance evaluations.
- Facilitates communication between Multicenter investigators, statisticians, research staff and programmers, especially during site assessment for feasibility/selection and monitoring for progress. Serve as a point of contact for questions from participating study sites.
- Reviews and provides feedback to MCCs as well as outside site personnel such as investigators regarding detailed and potentially complex monitoring and auditing findings and queries.
- Verifies and ensures accuracy of MCCS correspondence to outside sites, requiring comprehensive level of knowledge of applicable regulations and ICH guidelines, multicenter research best practices, COH policies and procedures, and specific protocol requirements
- Takes leadership responsibility for prioritizing urgent requests submitted by multiple sites
- Identifies and communicates important study and management issues or problems areas to Director and appropriate project staff.
- Serve as the liaison between the drug manufacturer, lead PI, and study staff at participating sites
- Keep abreast of new internal and external developments related to the conduct, management and monitoring of multicenter research. Serve as an institutional resource for the complete and correct application of federal regulations, NIH guidelines and industry best practices for the start-up and monitoring of multicenter research. Assess COH practices for alignment with federal regulations, accreditation standards, and best practices related to the conduct of multicenter research.
- Significantly contributes to the CCSG Competitive Grant Renewal submission, the annual progress reports for the Clinical Protocol & Data Management section as well as material for Cancer Center External Advisory Committee Meetings. Responsible for developing materials and support the NCI site visits as needed.
- Serves as a subject matter expert to provide feedback on study-related documents, including (but not limited to), study protocol, informed consent template, Manual of Procedures, Case Report Forms, especially when protocols are transitioning from single-center to multi-center.
- Assists investigators in conducting site feasibility to ensure that site can appropriately accrue to the study prior to effort in site initiation as well as providing relevant information for budget development
- Ensures that Site Initiation Visits are coordinated in a timely fashion and upon request and as needed will support the regulatory aspects and data collection aspects of the SIV. Ensures MCCs have prepared agendas and supporting information/documents appropriate for the study. Develops and conducts training for staff and coordinators involved in the project with the assistance of the COH Research Coordinators assigned to multicenter coordinators. Ensures SIV is appropriately attended and maintains attendance documentation.
- Responsible for ensuring completion, collection, maintenance and management of all regulatory documents from the participating sites
- Manages the Serious Adverse Event and Unanticipated Problem reporting process (receiving information/documents from sites, communicating with lead PI, assisting in preparation of necessary FDA notification, assisting in the preparation of necessary site/sponsor notification, etc.)
- Responsible for collating necessary information required by the COH DSMC and disseminating DSMC reports to participating sites and drug manufacturer as necessary.
- Facilitates management of IND processes and required documentation with OIDRA
- Drafts and disseminates protocol modifications as directed by lead PI and/or OIDRA
- Establishes SOPs for Investigational Product and Device accountability and distribution.
- Responsible for study close out at each site.
- Use established metrics, and participate in the development of new metrics. Use quantitative and qualitative metrics, along with various forms of stakeholder feedback, to identify performance improvement opportunities and implement process improvements.
- Participates in ongoing clinical research performance improvement initiatives.
- Responsible for maintaining electronic systems for effective receipt, logging, tracking, and management of documents related to the management and monitoring of multicenter research. Such systems may include iRIS, eReg Binder, OnCore, and MIDAS as well as the case reporting form system.
- Ensures that sites have system access to the systems they need to complete registration and case report forms, as well as managing the studies at their sites.Ensures that sites have system access to the systems they need to complete registration and case report forms, as well as managing the studies at their sites.
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 shared, organization-wide competencies describe the desired behaviors that will facilitate success at City of Hope:
The position directly supervises:
- Multicenter Coordinator(s)
The position collaborates with:
- Investigators and research staff at non-COH participating sites
- Bachelorâ€™s degree is required; Masterâ€™s degree is preferred. Experience may substitute for minimum education requirements.
- Six 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. At least 2 years of experience directly related to Multicenter research is required; and at least 4 years of experience providing direction on interpreting federal, state, and sponsor policies and regulations in a clinical research setting required.
- Degree in biological, health sciences or related field is preferred
- Certification through SoCRA or ACRP
- Prefer experience in clinical research settings, ideally cancer trials
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) Guidelines. Strong Communication and interpersonal skills, including good command of English Language. Strong organizational and problem solving skills. Good team leadership skills; effective mentoring and training skills. Ability to manage competing priorities
- Microsoft Office Suite
- Computer, approximately 80%.
Working / Environmental Conditions:
- Work is primarily performed within an office setting. Frequent meetings and walking to meetings, work long hours. May require occasional travel
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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