The Heart Center Clinical Research Core Manager (HCRCM) provides leadership, strategic management, and administration for the clinical and translational research program of the Heart Center. The HCRCM supervises and manages the research staff in the Heart Center Research Core within the Stanley Manne Childrens Research Institutes Center for Cardiovascular Innovation. The Heart Center Research Core (HCRC) serves as the key operational interface between the funding agencies, industry partners, the clinical and translational research program within the Stanley Manne Childrens Research Institute at the Ann & Robert H. Lurie Childrens Hospital of Chicago, sponsored programs, research team and principal investigators. The HCRCM will be responsible for the management and oversight of pre-award and post-award activities and finances relating to sponsored research studies for the Heart Center in conjunction with the Office of Sponsored Programs. This includes preparing research budgets, contract negotiations and post-award management. The HCRCM will communicate accurate and timely financial and research data to principal investigators, sponsors and others. The HCRCM will provide proactive financial advice, planning and maintain a strong customer-service oriented environment and promotes employee satisfaction. The position will implement policies and standard operating procedures to ensure compliance with sponsor rules and regulations and generally accepted accounting and clinical research procedures. The HCRCM will work with minimum direction and guidance within a service-team environment. The HCRCM models and supports the principles of good clinical practice with the research team. The HCRCM will report to the Heart Center Administrative Director and the Director of Research and Academic Affairs.
1. Manages and directs the HCRC project portfolio.
2. Facilitate the generation and management of the HCRC project portal
3. Design and maintenance of the participant/research database and methods for document retrieval
4. Assists principal investigators in preparing applications for funding and managing existing grants and contracts.
5. Monitor and maintain completion of Cardiovascular Research Review Committee Proposals and submission to IRB and OSP (if applicable)
6. Facilitate the preparation, review and approval of all study documents, agreements, contracts and reports.
7. Facilitate systems and processes that will add with the logistics associated with study initiation-ordering/acquisition of study related supplies, coordination between internal or external departments or sites, training and instruction of the study team and ancillary staff, research registration and billing, maintenance of source documents and study binders.
8. Implements and interprets research and financial policies and procedures in conjunction with the Office of Sponsored Programs.
9. Works with faculty to identify new federal and foundation funding opportunities, provides insight on funding terms and conditions and submission requirements.
10. Prepares and submits regulatory documents to the government and/or sponsor and provides oversight to other research staff responsible.
11. Ensures proper post award account creation in ARHLC financial systems, including Lawson, payroll, EPIC and purchasing based on specific grant or contract language. Coordinates sub-award agreement creation and monitoring with OSP.
12. Monitors funds on weekly basis, reconciling faculty and staff salaries, subcontractor invoices, incoming sponsor payments, cost transfers and other allocable expenses ensuring financial compliance to reporting standards and funding agency requirements.
13. Provides regular financial status updates including fiscal projections to PIs and director and processes spending plan adjustments at the direction of faculty to meet project objectives.
14. Reviews and coordinates time and effort reporting for faculty and clinical research staff. Works with PIs to regularly monitor information and make changes as appropriate.
15. Ensure timeliness, availability and security of research information when exchanging information.
16. Responsible for timely assembly and production of annual federal/sponsor progress reports, just in time submissions, no-cost extensions, contract amendments and assists in the completion of required financial reports with OSPA.
17. Oversees and provides guidance to other research staff in study procedures and processes and monitors team workflow.
18. Serves as clinical research leader internal and external and advises other staff regarding complex protocols and projects.
19. Works with the clinical research team to ensure proper invoices are generated in a timely fashion on all studies, offering training and guidance as appropriate;
20. Assists principal investigators with internal and external budget development for grant applications, including negotiation of budgets with sponsor.
21. Works with the Office of Sponsored Programs to facilitate contract negotiations and execution.
22. Provides oversight of patient charges to fund accounts; verifies accuracy of all charges to fund accounts including salary and miscellaneous expenses.
23. Oversees research fund closeout in conjunction with clinical research staff, OSP, OSPA and sponsor.
24. Attend and participate in investigator meetings as needed
1. Establish and execute strategic objectives of HCRC in collaboration with the Director of HCRC and the Heart Center leadership team.
2. Provide, communicate, and implement strategic, operational and programmatic plans and policies to achieve the vision, mission, and values of Lurie Childrens, the Heart Center, and HCRC.
3. Position HCRC to successfully develop as a national leader in clinical and translational research.
4. Develop the necessary infrastructure and operational systems to increase and sustain high levels of research productivity.
5. Lead the development and implementation of research systems and processes to improve HCRC overall productivity and efficiency and position HCRC for sustained growth by: Integration Management, Scope Management, Cost/Time Management, Communication, Research and Project Quality & Risk Management.
6. Assist in the planning, design, measurement, assessment and improvement of services provided by HCRC.
7. Collaborate with Heart Center leadership and the Director of HCRC in short and long term strategic planning.
8. Organize and conduct annual research needs assessment.
9. Ensure the development of organization-wide materials, products and standards for communication about HCRCs results and activities (e.g., web site, informational materials).
Leadership: 1. Works with other departments/disciplines to provide leadership for all aspects of research projects (new project development efforts and existing), including development of scope of work, budget and managing contract negotiations, and execution, and billing and reimbursement.
2. Interact and communicate extensively with HC leadership, sponsors, and stakeholders: chair and conduct key customer meetings; facilitate HCRC project portfolio status reviews, and risk meetings with leadership.
3. Serves as a liaison between the faculty and OSP, sponsors, CROs, Federal agencies.
4. Participates in division research meetings and sponsor study meetings/teleconferences.
5. Manage issues and risks and resolve conflicts. Keep stakeholders informed of progress and issues escalate as necessary.
6. Recruits and supervises research personnel, including training and mentoring research staff and providing opportunities for staff education, development, and professional growth.
7. Works with clinical leaders and staff to educate and engage patients and families in clinical research.
8. Establishes strategic plans, policies, and procedures to assist the division and department in fulfilling its research goals and objectives.
9. Promotes the research activities within the division and participates in local and national meetings and works with the faculty to report results via publications and presentations.
10. Support Lurie Childrens business-related processes, procedures, best practices, and relevant applications. 11. Produce financial, narrative and annual performance reports about HCRCs activities.
Management: 1. In collaboration with the HCRC Director, assume overall clinical research operational responsibility.
2. Monitor, direct and perform day-to-day operations to ensure policies and procedures are being followed, objectives are being met and that services and projects are run efficiently and effectively.
3. Plan, direct, schedule and manage resources and efforts of teams to support the operational needs and strategic objectives.
4. Develop internal processes that will clarify roles and expectations, promote research collaboration, and enhance the education, development and productivity of HCRC professionals.
5. Monitor timelines, milestone achievement and priorities.
6. Analyze issues, take corrective action, and intervene when necessary.
7. Monitor and respond to situations that affect daily operations.
8. Develop and present reports and metrics to evaluate productivity, internal processes, the adequacy of organizational capacity, and funding utilization.
9. Work effectively across the organization both internally across functional units within The Heart Center and with other Divisions and Centers at Lurie Childrens and externally with sponsor organizations and staff to ensure effective and efficient clinical research.
10.Develop and improve operational processes, and manage complex operations.
11.Responsible for directing clinical and translational research support personnel.
12.Manage the recruitment, selection, development, supervision, evaluation and discipline of reporting personnel.
13.Make job requirements and goals for each position clear to employees and provide sufficient training to achieve the desired level of results.
14.Document evidence of competence on an annual basis.
15.Establish orientation, training and continuing education programs to ensure competency of staff.
16.Administer the development of training plans for Good Clinical Practice, standard operating procedures by all staff and compliance with documentation of training.
17.Collaborate with patient services to ensure integration and understanding of the complementary roles of clinical research and clinical management, including developing in-service materials for new hires.
18.Collaborate with Heart Center finance leaders to prepare, coordinator, evaluate and manage annual fiscal operating and capital equipment budgets. 19.Forecast resource needs including planning for staff, space, IT support and all resources necessary for effective and efficient organizational structure to support clinical and translational research operations.
20.Establish a robust informatics infrastructure in support of clinical and translational research.
21.Participate in the selection of sources for necessary services not provided by Lurie Childrens.
22.Facilitate systems and processes for efficient preparation and submission of IRB documents and other documents required by regulatory agencies, conduct and summary of quality assurance and quality control checks.
23.Facilitate the maintenance of study records in compliance with regulatory guidelines and monitoring of study team compliance with study procedures and standards.
24.Facilitate the documentation and report of study events, protocol violations, amendments and continuing reviews.
25.Prepare for and respond to sponsor or regulatory audits.
26.Ensure compliance with regulatory agencies, adhering to GCP and Code of Federal Regulations guidelines, all applicable AAHRPP, JCAHO/PHRP standards.
1. Bachelors degree in business or accounting preferred and/or three or more years prior experience in providing financial management services on NIH and other federally funded grants or contracts directly for faculty and physicians in an academic research/hospital environment is required. Experience in clinical research financial management or research award administration.
2. Demonstrated track record in a front-line service-oriented position, involving extensive customer contact and relationship building.
3. Expert knowledge of FDA guidelines and good clinical practices.
4. ACRP or SOCRA certification
5. Must possess strong interpersonal, written and verbal communication skills, and be detailed oriented. Must possess the ability to communicate effectively with physicians, investigators, medical center personnel, external funding agencies, and to maintain a variety of internal and external contacts.
6. Excellent leadership skills, ability to work with a team, excellent oral and written communication skills, good analytical ability, excellent organizational skills, understanding of financial budgets and reports, knowledge of hospital information systems.
7. Candidate must be able to make independent decisions, establish priorities, and react promptly with minimal supervision and a high level of discretion and confidentiality.
8. Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
9. Demonstrated knowledge of Microsoft Office and other computer software is required.
10. Experience with Cayuse 424/SP helpful
11. Knowledge of OMB circulars including A-21, A-110, cost accounting standards, indirect cost rate application, FAR and CFR.