Under the direction of the Clinical Operations Director of Research Administration, the Research Clinical Operations Manager is accountable for the leadership efforts of the Office of Research Administration as it relates to the research program of MemorialCare Health Systems. The responsibilities are broad and diverse to include personnel management, physician relations, customer service, oversight of study patient screening and enrollment, tracking of clinical trial progress, compliance with regulatory standards, and the general oversight of the research process. This position is responsible for the direct oversight of the research staff and for the performance of staff members when involved in research (e.g., Regulatory Affairs Coordinators, department secretaries, and clinical staff such as coordinators, technicians, service line liaisons, and practitioners).
This individual will initiate and maintain relationships with the research community of MemorialCare Health Systems, clinical research staff, investigators, external companies, academic leaders as well as organizational executives. The Research Clinical Operations Manager will interact with all levels of management, including the Office of Research Administration, to plan, organize, lead, and monitor the scientific and clinical performance of research and ensure regulatory compliance. This individual orchestrates the long-term viability and growth of the institutions research programs by working closely with industry as well as our physicians to participate in clinical trials that will benefit our community by leveraging the expertise of our clinicians.
Principal Duties and Responsibilities:
Establish, evaluate, and oversee clinical and administrative operations, regulatory compliance, policies and procedures training and education for the Office of Research Administration clinical operations division.
Manages and provides direction and leadership to clinical operations team
Oversight and monitoring of all MHS clinical trials as it relates to the assigned campus
Identify and communicate study-related issues. Facilitate and implement solutions with the research team
Present significant research efforts, findings, outcomes, and approvals internally and to external audiences
Utilize critical insight to evaluate and select research studies in conjunction with the Director of Clinical Operations and the associated Principal Investigator
Lead new research initiatives by engaging other therapeutic area specialists to assess their areas of interest within clinical research
Identify targets of opportunity both within the health system and with outside partners by exploring ways to integrate research opportunity within their practice area
Provide general leadership in relation to each individual trial and effectively collaborate with other departments to meet all timelines and goals
Independently oversees the functionality of study related documents such as Source Document Worksheets, Informed Consent Checklists, Concomitant Medication page etc.
Assure all aspects of research are compliant with regulatory and study standards
Ensures timely follow up of industry research contracting execution (including Clinical Disclosure Agreement and Clinical Trial Agreement and Letter of Agreements)
Consideration of the financial integrity of all studies by overseeing the time and effort tracking for all staff involved in relation to each trial. Responsible for the oversight of clinical research billing. Conducts monthly study budget reviews with executive leadership, plans, and implements change
Oversee research laboratory/pharmacy support services for research studies
Fosters collaborative relationships with other departments, entities and community organizations to facilitate and support the mission, vision and goals of research
Identifies and directly confronts issues which affect quality of service; collaborates with staff, manager and physicians to resolve these issues
Utilizes collaborative communication techniques to achieve positive outcomes in all interactions
Prepares accurate and timely written reports, statistics and other documentation as necessary or as requested
Effectively manages change processes as they impact research operations and staff
Maintains ongoing analysis of research performance and financial trends and opportunities
Presents to work on time, follow organization rules, policies, procedures and directives
Effectively interacts with staff in a positive and constructive manner
Ability to make suggestions for enhancements throughout the department and continually seeks opportunities to improve current policies, procedures and practices while prioritizing the tasks assigned