Under the direction of the Executive Director, the Director of Research Clinical Operations is responsible for providing overall administrative leadership, business development and operational management of the MemorialCare Health System research program as well as the associated quality and administrative functions of the clinical research activity. The Director will oversee all aspects of research conducted at MHS including seeking out clinical trial opportunities, collaborating with the Principal Investigators to support their research endeavors, coordinating all study information and activities, and working with physicians/clinicians and external research companies to differentiate the MHS research program.
The Director is expected to emphasize appreciation and responsibility for research compliance, collaboration among research disciplines, investigator engagement, the support for a clinical trial management software solution, as well as strategizing for new business and pipeline development opportunities, generating a positive return on investment related to project-specific research endeavors, and building a culture of robust clinical trial integration throughout our MemorialCare Health System.
Principal Duties and Responsibilities:
Provide oversight for the day-to-day clinical research operations in conjunction with the Executive Director of MHS Research; determining the short and long-term vision for MHS Research
Direct the clinical research operational requirements of the department and ensure efficiency and effectiveness in the activities of clinical operations so that resources are used to assist in achieving the goals of the department
Maintain liaison with the MHS research community and work in collaboration with Executive Director and senior leadership to request support and problem solve
Direct the overall distribution of research trial support, system-wide
Develop the overall pipeline development strategy undertaken each FY for the Clinical Operations division of the Office of Research Administration
Provide regular reports including performance metrics and program evaluation, such that various stakeholders have insight to program progression
Exercise financial and contracts management oversight over all sponsored and internally funded research accounts
Ensure coverage analyses, budgets and are developed and billing plans are implemented for all clinical trials prior to trial implementation
Work collaboratively with Research Finance to ensure accountability for charges to the research accounts and the monitoring of milestones, accounts receivable, and accounts payable
Serve on committees as appointed by the Executive Director
Manage the department budget as directed by Executive Director, Director of Research Finance or designee
Provide the Executive Director, or designee, with fund projections and staffing lists for both research and support staff on a regular basis
Information Systems Management
Work collaboratively with the Development and Technology team to bring forth a research submission process platform to assist in the trial submission and tracking component of clinical trials
Work collaboratively with the Development and Technology team in order to transition into CTMS environment
Develop a high degree of understanding of the CTMS functionality and use cases
Oversee clinical research informatics touch points within the clinical research operations teams as applicable.
Human Research Protections Management
Ensure post-approval monitoring of trials
Complete a high-level overview of audits, review audit findings and discuss with clinical research staff
As necessary, design and implement process improvement plans in collaboration with HRP leadership to facilitate clinical operations
In conjunction with Executive Director, identify and analyze business opportunities to include partnerships with academia, industry, technology companies, industry-funded, and investigator-sponsored research awards, etc.
In conjunction with the Executive Director, develop and implement and/or support a clinical trials pipeline function that will effectively promote and engage MHS researchers, attract additional funding into the MHS Research Program , provide access to care for patients, and ultimately drive revenue from commercial sources
Identify and build a robust team of skilled investigators that broaden the umbrella of therapeutic areas represented by MHS
Classify and manage allocation of professional resources for MHS researchers to include protocol development, statistical modeling and analysis, scientific writing, etc.
Assist researchers in developing process to analyze demographics, quantify potential sample size based on key eligibility criteria and/or identify potential research participants on approved MHS research trials.
Provide direction and guidance to clinical research direct reports and serve as a management resource for onboarding
Manage writing of job descriptions, hiring, layoffs, terminations, evaluations, record keeping and other aspects of personnel management
Provide direct supervision to the Manager(s) of clinical operations, as well as support for all research staff, provide staff training as necessary, prioritize and assign work to the designated research staff and follow up to ensure accurate and timely completion of work
Coordinate Manager-level work and responsibilities, as well as to assist staff by answering questions and informing them of changes in procedures
Hold regular meetings with department personnel to discuss progress, process improvement, initiatives and issuing of guidelines for internal procedures. Cascade information from the Executive Director or designee or other leadership meetings attended by the Director
Demonstrate ability to supervise and motivate all personnel within reporting structure, including interviewing, selection, training, performance reviews and disciplinary action
Provide exceptional customer service to the research community
Ensure adherence to Memorial Health Systems policies, procedures, compliance and practices by all staff under this span of control
The Director of Research Operations must possess deep content expertise in clinical research operations as well as clinical trials management and have a proven track record of excellent leadership required for fostering effective collaboration between MHS executive leadership and research operations leadership