Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. 

Under the direct supervision of the Vice President, Strategic Partnerships and Startup (VP SPS), the Director, Clinical Trials Startup and Feasibility provides consistent leadership and general oversight of the daily administrative activities of the startup regulatory and feasibility teams responsible for the interventional clinical trial portfolios managed within System Clinical Research. 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 System Clinical Research in the development of best practices and tools for protocol execution, management and oversight in the feasibility and startup process. The Director ensures strong communication with internal and external parties along with regulatory compliance). The candidate has a significant impact on the ability to effectively implement quality and efficient feasibility and startup processes for 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 SPS. 

The candidate requires a strong understanding of clinical trial feasibility, startup, 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 System Clinical Research staff.  

S/he will manage the end-to-end feasibility process working cross functionally with Investigators, Finance, Clinical operations and additional personnel providing insight and proper pathways to analyze new trials coming into City of Hope leveraging data to ensure we are appropriately bringing in the right trials to CoH for review. S/he will impart specialist knowledge, deep understanding and detailed intelligence on the type of trial, therapeutic area, capability needs across research location and key obstacles to address trial selection parameters at CoH. With this information, s/he will present the feasibility data to our internal Stakeholders and Senior Management as well as developing mitigation strategies for consideration. S/he will be accountable for the successful delivery of feasibility activities for all clinical trials coming through COH. 

It is expected that the Director will collaborate internally under general direction from the ED SPS and will be responsible for the independent management of startup regulatory staff and feasibility personnel. . The Director serves as a subject matter expert and provides training and oversight to the startup and feasibility teams, leveraging the managers to determine the feasibility and value of endorsed clinical trials, and successful management and execution of startup process of every clinical trial. Further, s/he will assist the ED SPS in the long-term planning for the Startup group, and ensure fiscal responsibility and oversight. The Director is expected to work closely with the clinical trials business and administrative operations team, site operations team, research quality and oversite group and the Clinical Research Technology and Data Solutions team, in addition to the committee review groups. 
The Director will lead the startup and feasibility 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.

The Director, Startup and Feasibility also facilitates efficient and effective communication between each modality / disease research team(s) and its clinical research infrastructure / support service providers as it relates to the COH system wide research sites.  The Director assures that all COH clinical research meets the highest standards for speed, safety, effectiveness, and quality in a manner that enhances the clinical reputation of the organization both nationally and internationally.  The position requires close collaboration with the Associate Director, Clinical Research/Medical Director of the Clinical Trials Office as well as the Co-Medical Directors, Briskin Center for Clinical Research for the City of Hope's comprehensive cancer center to achieve these objectives:

Demonstrate expertise in a variety of fields related to the conduct and management of a robust and vibrant clinical oncology portfolio which encompasses all study phases and to a lesser extent HIV/AIDS and Diabetes research.Rely on experience, expertise and judgment to define and accomplish goals.Facilitate communication among leaders and stakeholders at all organizational levels.Lead and direct the work of others to oversee the conduct innovative clinical trials and advance the standard of care towards best practices in clinical research.Development and effective implementation of performance metrics which drive cost efficiency and optimal results

Operational Management

In collaboration with Associate Director, Clinical Research/Medical Director of the Clinical Trials Office as well as the Medical Director, Briskin Center forClinical Research Unit, evaluate and optimize clinical research modality / disease research team(s) in terms of, performance for feasibility and startup processes.Create and manage an efficient and proactive feasibility process to address the needs of system wide locations and assure CoH is opening the right studies at the right locationsDevelop, deploy, and revise SOPs as necessary to (1) proactively detect, eliminate and prevent regulatory compliance issues (2) minimize institutional risk and (3) maximize cost recoveryCreate and disseminate CTO startup performance summaries, scorecards and dashboards to facilitate ongoing quality and performance improvement initiatives.Regular review of current processes and procedures.  Review and implementation of best practices from literature and interactions with peer organizations.Collaborate with Clinical Research Contracting, budgeting and billing 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.Confirm that subordinates receive all necessary operational and educational training required to understand and comply with operational expectations.Ensure that CTO processes are well-integrated with the IRB’s processes.Address issues of non-compliance with the Executive Director of Research Protections to better integrate regulatory clinical trial activities and enhance the quality of the clinical trials that are conducted at COH.  Regular review of current processes and procedures.  Review and implementation of best practices from literature and interactions with peer organizations.In conjunction with the Executive Director of Research Protections, monitor all aspects of CTO operations to ensure institutional compliance with all applicable Federal, State, and Institutional requirements.

Regulatory Management

Provide leadership and oversight in the monitoring of startup regulatory compliance. Provide training and encourage ongoing educational opportunities to staff.Explore methods to reduce the number of deviations and findings and implement training to ensure compliance with all corrective action plansAssist in the development of Fast Track Policy and Procedure which includes recommending an IRB of choice for Fast Track; developing criteria to differentiate Fast Track from High Priority and communicating the Fast Track Policy and Procedure to StakeholdersParticipate in further streamlining and simplifying the informed consent documentation and guidance Support streamlining and launching all iRIS application forms related to human subject research Participate in revising and launching all action notices for uniformity, standardization across all committees, as well as ensuring only appropriate information is included 

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. 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 startup 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.

Professional Development

Enhance knowledge in field.  Keep abreast of changes in clinical research best practices.Participate in continuing education courses; attend seminars and forums related to clinical research.Read books, journal articles and government publications.Conduct and host site visits with professional peers to identify best practices and develop a professional network.Participate in institutional benchmarking studies.

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.

Qualifications

Your qualifications should include:

Bachelor’s Degree, Master’s Degree Preferred10 years of related experience with 5 or more years in supervisory/managerial level experienceor Master’s Degree plus 8 years of related experience with 4 or more years of supervisory/managerial level experience.

Preferred qualifications:

Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) certification

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

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