Director, Clinical Trials Office

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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 nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

Under the direct supervision of the Vice President, Clinical Research Operations (VP CRO), the Director, Clinical Trials Office (CTO) provides consistent leadership and general oversight of the daily administrative activities of the regulatory teams responsible for the interventional clinical trial portfolios managed within the CTO. S/he will ensure execution of appropriate and standardized practices 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. The Director ensures regulatory 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 teams to consistently meet and exceed standards. S/he makes decisions independently and oversees important activities relevant to clinical research activities at COH with the support, oversight and supervision of the VP CRO.

The candidate requires a strong understanding of clinical trial planning, management and metrics 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 COH'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 VP CRO and will be responsible for the independent management of regulatory leaders and managers. The Director also serves as a subject matter expert and provides training and oversight to the regulatory teams, leveraging the managers 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 VP CRO in the long-term planning for the CTO, and ensure fiscal responsibility and oversight. 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 regulatory teams as s/he facilitates communication and serves 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.

Key Responsibilities include:

• Operational Management -Create and disseminate CTO performance summaries, scorecards and dashboards to facilitate ongoing quality and performance improvement initiatives.
• Lead the CTO through audit preparation and ongoing performance improvement opportunities identified during audits.
• Regular review of current processes and procedures. Review and implementation of best practices from literature and interactions with peer organizations.
• Collaborate with Clinical Research Services (CRS) staff in support of budgets that accurately reflect CTO support of trial and provide accurate and transparent contracts.
• Create and implement policies and procedures to ensure work standardization.
• Effectively communicate (written & oral) across the organization.
• Collaborate on optimization of research technology (OnCore and EPIC) and services.
• Planning and Goal Setting - 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 clinical research.
• Retrieve and deliver pertinent reports to leadership as requested.
• Provides input in the development of departmental Policies and Procedures.
• Lead and serve on working groups to enable City of Hope to meet its strategic goals.
• Attends all pertinent departmental COH and Working Group meetings.
• Quality Research Oversight - Ensures the department is following institutional, state 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.
• Collaborates with CTO Leadership to lead, manage and document performance improvement projects.
• Personnel Management - 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.
• Collaborate with human resources to provide counseling or performance improvement of staff as needed.
• Confirm that subordinates receive all necessary operational and educational training required to understand and comply with operational expectations.
• Manage and lead staff to develop collaborative working relationships within the department and with other departments as applicable.
• 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.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

Basic education, experience and skills required for consideration:

• Must have a Bachelor's Degree.
• Must have at least 10 years of related experience.
• Must have at least 3 years of supervisory/managerial experience
• An alternate to the above requirements is having a Master's degree with at least 5 years of experience and at least 2 years of supervisory/managerial experience.

Preferred education experience and skills:

• 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.
• Microsoft applications including word, excel and PowerPoint
• Other institutional software to be determined
• Computer, Telephone, Pager, Fax, Copier, Scanner
• May have limited exposure to biological waste and pharmaceutical agents
• Works in an office environment.
• Able to walk, stand, sit, type and operate a computer with moderate keyboard activity
• Minimal lifting. Moderate walking.
• Occasional prolonged standing/walking
• Occasional reaching, stooping, bending, kneeling, crouching

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.

• Posting Date: May 5, 2021
• Job Field: Clinical Research
• Employee Status: Regular
• Shift: Day Job