$80K — $100K *
The Research Operations Manager is primarily responsible for the management and oversight of all sponsored research activities, including pre and post-award administration. They will oversee all financial and research compliance responsibilities; monitor and maintain compliance through pre-award budgeting and application development and preparation, post-award budget forecasting, monthly review of budget status, existing and forecasted expenses and center budgets. Regularly collect, analyze and report performance metrics. Collaborate with Center Directors and staff to manage and advise on financial or other management issues. Manage research staff and provide productivity reporting to senior leadership to help identify funding gaps. Provide a single point of contact for research financial and administrative matters. The Research Operations Manager must also be knowledgeable and efficiently communicate with investigators and staff trained in a variety of specialties, including physicians, faculty, regulatory authorities and staff.
The Hepatology Section has made a commitment to maintain a high level of awareness and compliance with the highest standards of practice and with regulatory issues impacting research, clinical care and education. This position will ensure that the Section not only complies with these regulations and policies, but sets the standard of excellence in this area. This position will maintain an awareness of, and familiarity with, policies and procedures impacting the liability and responsibilities of the Hepatology Section and the Division of Gastroenterology as it pertains to research, clinical care and education.
• Independently develop, document and maintain policies and procedures for the C-LIFE Program with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines and best practices guidelines
• Design and implement procedures for protocol audits and research instruments as necessary
• Manage protocol compliance and ensure research data quality that correlates with research objectives
• Independently develop and implement research project policies and procedures for C-LFIE
• Execute projects successfully and complete within required periods to meet research objectives
• Initiate action to correct project problems (i.e. deviation from protocol requirements) to ensure research quality
• Oversee the implementation of research protocols for all research projects
• In partnership with the process partners ensure all protocol requirements are met
• Facilitate the study start up process, including but not limited to: CRBB budget development and negotiations, scientific review committee submission, IRB submission, and other relevant regulatory submissions.
• Expand and implement strategies to enhance patient recruitment, while maintaining close relationships with both internal and external partnerships
• Serve as the primary research administrator for the C-LIFE
• Create and manage submission progress reports for research within C-LIFE
• Prepare supporting materials and other proposal-related documentation as needed
• Ensure training and regulatory guideline compliance of research staff, as well as staff compliance with site standard operating procedures
• Ensure research projects are conducted in compliance with federal regulations, institutional/departmental guidelines and standards of Good Clinical Practice (GCP).
• Research project policies and procedures that meet research objectives that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).
Grant & Finance Operations
• Provide post-award support to external and internal awards that are housed within C-LIFE, including monitoring faculty and staff payroll distributions, purchasing equipment and supplies and budget creation and close-out
• Serve as the fiscal contact for gifts, events, matching and sponsorships
• Monitor research awards for compliance with university and sponsor policies
• Prepare analyses and forecasting reports for the Centers budgets, gifts and program funds
• Manage submission of grant proposals
• Manage the C-LIFE program and its special initiatives, developing new processes, forms, communications and materials
• Contribute to the development of narrative reports for program reviews and annual reports
• Prepare and update content for the C-LIFE website and other publications
• Identify opportunities for process improvements (i.e. identification of shared resources for faculty and staff)
• Act as the Center's hiring manager and work with the HR Manager on new recruitments
• Manage payroll and cost center allocations for all staff within C-LIFE
• Direct all Research Support Staff and identify team leads in each research group
• Lead the research team in the organization, schedules, and assign work to meet all study-related tasks
• Oversee research coordinators (4 FTEs currently) and their program duties
• Perform all aspects of supervision including hiring, training, time reporting and leave requests
• Provide leadership and mentorship to research staff to develop a broad and relevant skillset, and advise/implement educational opportunities for growth.
• Develop and maintain a healthy work culture, receiving and providing constructive work-related feedback
• Implement and monitor annual performance reviews and address any performance issues as needed
A combination of education and experience equivalent to a Bachelor’s degree in Social Sciences or a related field and 4 years of experience progressively increasing responsibility in work experience that demonstrates the abilities described below.
• Knowledge of IRB application processes and FDA regulations
• Excellent demonstrated professional level written and verbal communication skills.
• Highly organized and flexible in order to effectively manage rapidly changing priorities and demands, often with frequent interruptions.
• Proven ability to work independently, manage priorities, handle multiple projects, problem solve and exercise judgment in a highly dynamic environment.
• Able to independently determine appropriate communications and procedures.
• Solid critical thinking skills and the ability to collaborate closely with others.
• Experience working effectively with senior administrators and professionals, including sensitivity to handling urgent matters in a thoroughly professional and timely manner.
• Proven customer service orientation with demonstrated interpersonal communication skills.
• Experience with Microsoft Office and other similar programs
Familiarity with clinical and translational research in complex academic programs with particular emphasis on the interrelationship between clinical, research and educational requirements of subspecialty medical training programs.
Valid through: 11/12/2021
$100K — $150K *