City of Hope Director - Clinical Research Systems Operations in Monrovia, California

Job Title: Director - Clinical Research Systems 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 nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary:

Reporting to the Senior Director of Research Applications and Data Management (RADM), the Director, Clinical Research Systems Operations is responsible for:

  • Oversite of operational support of the institutional Clinical Trials Management System (CTMS), setting the operational support and vision for research in the City of Hope (COH) Electronic Medical Record (EMR) system, ensuring the alignment of processes and functionality between the CTMS and EHR, and directing all quality control between these the systems
  • Partners with leaders in the Clinical Trials Office (CTO), Clinical Research Unit (CRU), Research Protections Unit (RPU), Clinical Research Services (CRS), and Research Business Operations (RBO) to ensure both systems are meeting the operational needs of each domain
  • Facilitates efficient and effective communication between departments to ensure that COH research meets the highest standards for speed, safety, effectiveness, and quality in a manner that enhances the reputation of the organization both nationally and internationally
  • Responsible for administrative leadership, policy and procedure development, operational oversight, training and support to system users and will drive alignment of use across the CTMS and EHR systems.

Essential Functions:

OnCore and OnCore Operational Management

  • Sets vision and implements structure for system training, testing, and operational support.
  • Manages the post-implementation usage, identifying required system modifications, new opportunities to enhance the usefulness of existing technologies and adding appropriate new technologies.
  • Works closely with the vendor to understand product roadmap, timelines, and impact of upcoming product releases.
  • Produces reports and metrics for leadership and others as needed.
  • Develops and maintains standard operating procedures (SOPs) and workflows that govern the use of OnCore and Epic across City of Hope.
  • Drives alignment of business process between OnCore and Epic.
  • Develop and implement roadmap for system enhancements and upgrades.
  • Coordinate with ITS to ensure all aspects of the clinical research systems are fully supported.

OnCore and Epic Quality Control

  • Directs support of workflows developed as part of the implementation of OnCore.Works closely with IT team lead to ensure that modifications in workflows are regularly communicated and documented.
  • Implement and maintain quality control process to monitor and correct integrations between OnCore and Epic, including calendars, budgets, and any other data exchanged between the clinical research systems.
  • Establish and maintain policies and procedures for quality control and quality assurance of operational data in OnCore and Epic.
  • Coordinate with stakeholders regarding data needs for quality assurance of clinical trials and clinical research.
  • Develop and implement strategies and processes to ensure data quality for the OnCore study calendar integration, patient status and study status between Epic and OnCore.

Personnel Management

  • Work on identifying areas requiring process improvement or compliance, and collaboratively develop solutions.
  • Work with direct reports to resolve personnel issues.
  • Attend and participate in departmental staff meetings.
  • Create new job descriptions with distinct roles and responsibilities for existing management and staff positions (with assistance from HR).
  • Support staff training, education and development.
  • Recruit and retain high quality staff members.
  • Conduct performance appraisal of direct staff using input from others where applicable.
  • Maintain effective communication with supervisors, program leaders, faculty, managers and staff.
  • Participate in short- and long-range planning and policy or program development by analyzing operational policies, resource utilization, etc. and developing recommendations for department management.
  • Performs other related duties as assigned or requested.

Position Qualifications:

Minimum Education and Experience:

  • Bachelor’s degree in business, finance, business administration, research administration, healthcare or related field.
  • Seven (7+) years of experience in business, finance, business/systems administration, clinical/research administration, science or related field.

Preferred Education and Experieince:

  • Advanced graduate degree preferred in clinical, research, pharmaceutical science or related healthcare field (e.g. MS/MA, PharmD, MSc, MRes, PhD, MSN, DNP, etc.)
  • Strongly preferred prior experience using CTMS and EHR systems.
  • Additional experience with clinical research, clinical trial management and/or clinical operations software systems is a strong plus.
  • Clinical research experience is strongly preferred in addition to experience in academic research environment or Comprehensive Cancer Center.

Skills/Abilities:

  • Strong written and oral communication skills, attention to detail, customer service orientation and proven ability to perform work accurately and efficiently. Outstanding work ethic and excellent attendance record.
  • Demonstrated ability to work independently and with a team. Excellent organizational and analytic skills, with the proven ability to multi-task, trouble shoot and prioritize work.
  • Demonstrated knowledge regarding requirements for research involving human subjects and or clinical background and experience. Experience with clinical trials financial management preferred for study calendar creation.

Software:

  • Microsoft products, required
  • Word Processing applications
  • Spreadsheet applications
  • OnCore CTMS

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 dis ability. # LI-DA1 | *CB-DA dice