Dir, Clinical Trials 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.
Under the direct supervision of the Senior Director of the Clinical Trials Office, the Director, Clinical Trials Office provides consistent leadership and general oversight of the daily activities of all clinical research teams and interventional clinical trial portfolios managed within the Clinical Trials Office (CTO), to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. S/he supports research operations strategic priorities to enhance interdepartmental communication and collaboration and leads the CTO in the development 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 candidate has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements by developing standards and teams that consistently meet and exceed standards and SLAs. S/he makes decisions independently and oversees important activities relevant to clinical research activities at COH with the support, oversight and supervision of the Senior Director, Clinical Trials Office.
The candidate requires a strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables simultaneously. S/he needs strong leadership skills (scientific and business) and ability to coordinate and lead teams to high performance. The candidate must work to build and maintain relationships with investigators and other external partners and promote COHâ€™s reputation. S/he is responsible for quality and compliance in all trials managed by CTO staff.
It is expected that the Director will collaborate internally under general direction from the Senior Director of Clinical Trials Office and will be responsible for the independent management of CTMs and Portfolio Supervisors. The Director also serves as a subject matter expert and provides training and oversight to the portfolio supervisors, leveraging the CTMs to determine the feasibility and value of endorsed clinical trials, and successful management and execution of all aspects of every clinical trial. Further, s/he will assist the Senior Director in the long term planning for the Clinical Trials Office, in addition to the management of the budgets of each of the studies conducted by the trams that s/he supervises. The Director is expected to work closely with the clinical trials billing team, in addition to other departments, such as Office of Sponsored Research, Office of Shared Resources, the Institutional Review Board, etc.
The Director will lead the CTMs as s/he facilitates communications and act as a liaison between the department and outside company sponsors, such as pharmaceutical and biotechnology companies. This position requires a high level of expertise, judgment, and analysis, with role based thinking to assist with extensive management demands. Requires independent decision making to prioritize requests and strong organizational skills to develop administrative systems and procedures.
- Create and disseminate CTO performance summaries, scorecards and dashboards to facilitate ongoing quality and performance improvement initiatives.
- Confirm that subordinates receive all necessary operational and educational training required to understand and comply with operational expectations.
- Lead the CTO through audit preparation and ongoing performance improvement opportunities identified during audits.
- In conjunction with the CTMs, update and enhance the protocol acuity scoring system, including validation of tool.
- Regular review of current processes and procedures.Review and implementation of best practices from literature and interactions with peer organizations.
- Collaborate with CTSS staff in support of budgets that accurately reflect CTO support of trial and provide accurate and transparent contracts.
Planning and Goal Setting
- Create and implement policies and procedures to ensure work standardization.
- Utilize rounding boards and staff huddles to support Organizational and CTO goals.
- Build and sustain relationships with internal and external stakeholders.
- Support the strategic plan for the organization and for clinical research.
- Lead departmental implementation of new technology (OnCore and EPIC) and services.
- Retrieve and deliver pertinent reports to leadership as requested.
- Effectively communicate (written & oral) across the organization.
- Lead and serve on working groups to enable City of Hope to meet its strategic goals.
Quality Research Oversight
- Ensures the department is following organizational and federal rules, policies and regulations regarding clinical research.
- Responsible for ensuring protocol compliance by staff and providing recommendations for corrective action when necessary.
- Meet regularly with disease program leaders, investigators and CTO Leadership to provide necessary updates.
- Communicate and escalate unresolved issues at the appropriate time to the appropriate level of management.
- Identify and initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work.
- Meet with internal and external monitors to communicate any issues or challenges and develop corrective action plans as needed.
- Provides input in the development of departmental Policies and Procedures.
- Collaborates with CTO Leadership to lead, manage and document performance improvement projects.
- Support efforts to recruit and maintain an adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements.
- In collaboration with CTO Leadership, develop, maintain and monitor staffing plan for assigned teams.
- Lead CTMs through development of Subject Matter Expertise (SME) roles.
- Collaborate with human resources to provide counseling or performance improvement of staff as needed.
- Manage and lead staff to develop collaborative working relationships within the department and with other departments as applicable.
- Attends all pertinent departmental COH and Working Group meetings.
Fiscal and Budget
- Provide financial input for annual budget preparations.
- Collaborate with CTO Leadership to identify disease team needs on a monthly as well as annual basis.
- Develops quarterly and annual staffing plan in collaboration with CTO Leadership.
- Identifies and communicates opportunities for improved efficiency and/or cost saving within the department.
- Provide input and support to CTO and Research Operations Leadership in the development of new programs or services or disease teams.
- Participates in operational and feasibility assessments performed within the disease programs.
- Bachelors Degree
- 8 or more years of related experience with 3 or more years supervisory/managerial level experience
Preferred Education and Certification/Licensure:
- Master's Degree
- Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) certification
- Strong verbal and written communication skills.
- Knowledge of Good Clinical Practice, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process.
- Ability to collaborate with internal and external stakeholders.
- Excellent interpersonal skills.
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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Sr Prospect Research Analyst
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