Manager, Research Site Operations
Manager, Research Site Operations
Medical Center - Duarte (Duarte, CA) Description
Position Summary and Key Responsibilities:
The Research Site Manager (RSM) provides consistent leadership and general oversight of the daily activities of the Clinical Research Coordinators (CRCs) to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. The RSM supports research operation strategic priorities to enhance interdepartmental communication and collaboration and assist in the development of best practices and tools for protocol execution, management and oversight as well as ensure quality data collection.
Planning and Goal Setting
- Update and enhance the protocol acuity scoring system.
- Create and implement policies and procedures to ensure work standardization where necessary
- Build and sustain relationships with internal and external stakeholders.
- Support the strategic plan for the organization and for clinical research.
- Support departmental implementation of new technology (OnCore) and services.
- Retrieve and deliver pertinent reports to leadership as requested.
- Effectively communicate (written & oral) across the organization.
- Serve on working groups to enable City of Hope to meet its strategic goals.
Quality Research Oversight
- Responsible for ensuring the integrity of data submitted by staff and providing recommendations for corrective action when necessary.
- Provide back-up support as needed for other RSMs and/or CRCs.
- Meet regularly with disease program leaders, investigators and Clinical Research Nurse Managers/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.
- Lead the preparation for external audits in collaboration with Research Quality Monitoring.
- Assist in the review of audited protocols for adherence, acts as the point person during the audit and works with the research team to construct responses to the audit report.
- 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 the Clinical Research Nurse Managers, Clinical Research Nurses and 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 the Clinical Research Nurse Managers/CTO Leadership, develop, maintain and monitor staffing plan for assigned disease programs.
- Responsible for the orientation and ongoing training and development of Clinical Research Coordinators and Biospecimen Coordinators.
- Directly responsible for the performance management of Clinical Research and Biospecimen Coordinators.
- Monitor time and effort tracking reports on a periodic basis and follow up as needed.
- Collaborate with human resources to provide counseling or performance improvement of staff as needed.
- Responsible for tracking the current status of certifications and any required competencies.
- Manage and lead staff to develop collaborative working relationships within the department and with other departments as applicable.
- Provide on-going training for iRIS users (or any other software used in Clinical Research) and provide instructions for the navigation of cooperative group websites.
- Attends all pertinent departmental COH and Working Group meetings.
Fiscal and Budget
- Provide input for the annual budget preparations.
- Collaborate with Clinical Research Nurse Managers and the CTO Leadership to identify disease team needs on a monthly as well as annual basis.
- Develops quarterly and annual staffing plan in collaboration with the Clinical Research Nurse Managers and CTO Leadership.
- Identifies and communicates opportunities for improved efficiency and/or cost saving within the department.
- Provide documentation to support the purchase of equipment, supplies and/or for department repairs.
- 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.
Disease Team Management
- Work in conjunction with the disease team program lead physicians, Principal Investigators, Clinical Research Nurse Managers and CTO Leadership to accomplish goals, projects and research initiatives for assigned disease teams.
- Collaborates across multidisciplinary teams.
- Provides guidance, direction and management regarding disease team meetings (e.g., Protocol Priority List, create agendas, minutes, coordinate speakers, scheduling, etc.).
- Prepare and review study documents to coordinate new study endorsements and outcomes.
- Oversees PMT reporting.
- Develops corrective action plans (CAPAs) as needed.
- Facilitates work associated with protocol amendments.
- Develops working relationships with study sponsors for future collaborations.
- Evaluates new studies for operational challenges and presents identified issues at disease team meetings.
- Meet with Clinical Trial Support Services (CTSS) to review study budgets.
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.
Minimum Education and Skills Required for Consideration:
- Bachelor’s Degree and Seven or more years’ experience as a Clinical Research Coordinator and supervisory experience. Master's degree is preferred.
- Requires a CCRP certification through Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
- 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. Knowledge of EPIC would be a plus.
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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.
City of Hope is 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.