Manager, LIBR Grants & Compliance
Saint Francis Health System
Job Summary: This position is responsible for management of all aspects of grant administration, institutional human subject's protection, and compliance with federal and state laws and regulations for the Laureate Institute for Brain Research (LIBR). Duties include compiling information for grants and contracts, reporting, tracking, and maintenance of data and documentation related to grants, ensure regulatory compliance; provide training and support for LIBR staff. Coordinate the Center of Biomedical Research Excellence (CoBRE) program grant.
Education: Bachelor's degree.
Licensure, Registration and/or Certification: None.
Work Experience: At least four years of experience in clinical research coordination, experience working with IRB or on an IRB in a healthcare or research environment. Experience working with federal regulators, FDA, NIH, IRBs, funding agencies, auditors, principal investigators, staff. Experience in designing and maintaining process and procedures for complicated transactions, and in developing systems for information storage and retrieval. Work experience in grants administration and biomedical research.
Knowledge, Skills and Abilities: Working knowledge of Federal Grants. Knowledge of federal and state research compliance regulations, institutional requirements. Ability to design and implement systems for education, monitoring, recordkeeping, and process design. Ability to work with people in variety of roles, both inside and outside of the institution. High degree of integrity, team orientation, professionalism, and trustworthiness. Excellent organizational and data management. Self-directed, persistent, capacity to work through difficult situations.
Essential Functions and Responsibilities: Pre-award Management. Oversee entire pre-award process: Identify funding opportunities; research and inform Investigators of specific application requirements by varying funding sources; manage timeline for application process keeping Investigators on pace for timely submission and ensuring proper administrative personnel are available on submission day; assist with budgeting, writing and compiling application information; review all applications prior to submission; monitor status of all applications submitted until final determination notification is received. Data Management, Record Maintenance, and Audit Responsibilities. Document grants management pre- and post- award processes and procedures. Maintain grant status report for upper management review. Transition relevant data to post-award grant file upon receipt of award. Develop system for maintenance of data, records, and files for all applications submitted by LIBR and all protocols, including quality control. Maintain updated documentation of standard information to be included in all applications such as Resources and Environment descriptions. Manage records of staff credentials, training program completion, and other information required for staff eligibility to conduct research. Post-award Management. Manage timeline for all non-financial post-award reporting and assist Investigators with timely submission of progress report. Function as liaison between LIBR and sponsor. Perform grant close-out procedures. Review budgets with Investigators. Oversee payments on subcontracts and for LIBR when LIBR is a subcontract. Manage P20 (CoBRE) grant. Ensure timelines are met, organize advisory committee meetings, arrange training opportunities, help manage website. Coordinate the pilot project program. Organize annual reports to study sponsor (NIGMS). Develop partnerships with other CoBRE and IDeA Networks in OK and neighboring states. Training and Education. Oversee the development and carrying out of educational programs necessary for staff training and certification as needed for human subjects protection, conflict of interest, research misconduct, etc. Provide training and support to LIBR staff in pre and post award procedures. Attend NCURA and other Federal grant training programs. Regulatory Compliance. Maintain comprehensive knowledge and understanding of all aspects of institution’s system of protections for human subjects, and commitments under Federal Wide Assurance. Exercise operational responsibility for LIBR's Human Subject Protection Program, including development, implementation, and maintenance of a system for efficient operations of the human subjects research compliance function. Stay current with federal and state laws and regulations, including those of DHHS, OHRP, FDA, and ORI. Serves on LIBR Compliance Team to implement, coordinate, and update institutional initiatives, policies, and procedures regarding privacy, data security, grants management, financial operations, FWA and other regulatory requirements for research and institutional compliance to ensure full compliance at all times. Coordinate with regulators, auditors, IRBs, collaborating institutions, and other constituents on issues of protocols, policies, practices, and human subjects' protections. Fully implement electronic consent process. Participate in quality control review of practices; institutional response to concerns or reports of misconduct, or improper procedures, or other noncompliance. Protocol and IRB Submissions: Represent institution and provide liaison with institutional and central IRB's on all research protocols, including submissions, changes, renewals. Make sure protocols and consent forms meet requirements for protection of human subjects and institutional compliance, prior to approving for submission to IRB. Oversee work plan and coordination of resources for upcoming new protocols, renewal of current protocols, and closeout of others as needed.
Decision Making: The carrying out of non-routine procedures under constantly changing conditions, in conformance with general instructions from supervisor.
Working Relationships: Direct supervision of others. Prepares and gives performance evaluations. Works with internal/external customers. Works with other healthcare professionals and staff. Works frequently with individuals at director level or above.
Special Job Dimensions: None.
Supplemental Information: This document generally describes the essential functions of the job and the physical demands required to perform the job. This compilation of essential functions and physical demands is not all inclusive nor does it prohibit the assignment of additional duties.Laureate Institute for Brain Research - Laureate Campus
Location:Tulsa, Oklahoma 74136
EOE Protected Veterans/Disability