1. Provides guidance to investigators and research staff to facilitate the ethical conduct of research by assisting with questions regarding submission preparation and requirements.
2. Triages submissions including amendments, adverse events, protocol violations and unanticipated problems.
3. Conducts regulatory review of initial, continuing and amended research protocol submissions for compliance with applicable federal regulations and federal policies.
4. Interprets applicable federal and state regulations when analyzing each submission to assign the regulatory risk determinations based on the research plan, study phase and methodology.
5. Provides written reports summarizing findings for review/approval by committee chair(s).
6. Provides direct feedback to investigators and research coordinators to guide them in making necessary modifications to submissions in order to meet regulations and obtain approval before and after the compliance committee meeting.
7. Initiates and participates in the development and maintenance of compliance programs, including but not limited to standard operating procedures (SOPs), educational/training materials, associated forms and policies, and is responsible for ensuring changes in regulatory and institutional requirements are integrated in draft SOPs and policies.
8. Assists with the development of databases, entering, tracking and monitoring submissions. Provides summary reports to the Director and Chair(s).
9. Maintains office files in accordance with regulatory guidelines (OHRP, FDA, etc.).
10. Determines appropriate risk category for exempt and expedited studies per all applicable regulations (OHRP, OLAW, NIH, FDA. etc.) before forwarding to committee/chair.
11. Prepares for and participates in research compliance board meetings (IRB, IACUC, IBC); agenda preparation, recording minutes, tracking member presence to ensure quorum, documenting vote, preparing meeting reviews and written follow-up reports/correspondence to investigators.
12. Develops, and implements a post-approval monitoring program and utilizes findings as a means to identify training opportunities or areas in need for process improvement; coordinates and conducts formal training of ORIC staff, investigators and research staff.
13. Assists in the preparation and conduct of compliance audits, accreditation applications, site visits and reports.
14. Identifies areas and then develops QA and QI initiatives including modifying reviewer checklists, updating forms, website improvements and development. Assures standards of required accrediting agencies (AAHRPP, ALAAC, etc.) are achieved and maintained.
15. Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients, families, co-workers, community outreach partners and others.
1. Bachelor's degree in a related field required.
2. Minimum of 4 years of related experience to include 2 years of clinical research compliance experience.
3. Certification in Research Compliance or related area required or eligibility to obtain certification within 6 months of employment.
4. Must possess strong written and verbal communication skills, and be detailed oriented.
5. Must possess the ability to communicate with all levels of faculty and staff within the institution in an accurate, helpful, and customer service oriented manner.
6. Must be able to make independent decisions and function independently with minimal supervision.
7. Candidate should be able to function with a high level of discretion and confidentiality.
8. Must maintain current knowledge of federal, state and local regulations pertaining to the conduct of research and research compliance, such as DHHS, OHRP, FDA, OLAW, and USDA.
9. Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
10. Maintenance of membership in a related professional organization and conference attendance is expected, such as PRIM&R.
Internal Number: 2019-10959
About Lurie Children's Hospital
All the commitment, all the services, all the care. All, for your one. At Lurie Children's, a top-ranked children's hospital, we put children and their families at the center of all we do — from before birth, through childhood and adolescence, and beyond. Because we're passionate about helping children become happy, healthy adults.