Job Description:

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.LocationAnn & Robert H. Lurie Children's Hospital of ChicagoJob DescriptionAssistant Director promotes the ethical conduct of clinical research and ensures compliance with all institutional, federal, state, and local regulations. Assists in the management of the day-to-day operations, personnel and processes of the Office of Research Integrity. Develops and implements systems for ongoing process improvement and program expansion in a manner that facilitates the ethical conduct of research and ensures compliance with all relevant governmental, institutional, and other applicable regulations related to the protection and rights of human subjects, HIPAA and research, management of conflict of interest, etc.Manages activities related to quality assurance and develop post-approval monitoring program of ongoing research protocols. Assures standards of required accrediting agencies (AAHRPP, etc.) are achieved and maintained. Prepares routine reports to regulatory bodies and accrediting agencies (OHRP, ORI, FDA, etc.) for review and approval by the Director, Office of Research Integrity and Compliance and Sr. Vice President and COO of the Research Center.Essential Job FunctionsSupports the strategic plan for growth and development of the Institution's research program.Assists in the management of the day-to-day operations, staff, and processes of the Office of Research Integrity and Compliance (ORIC) in order to support investigators and research compliance committees (IRB, IBC, etc.). Assures standards of required accrediting agencies (AAHRPP, etc.) are achieved and maintained. Leads preparation of accrediting agencies applications, site visits, and interim reports.Participates in the training, orientation, supervision and evaluation of ORIC staff. Provides recommendationsinput on hiringtraining, revisions of job descriptions. Plans and conducts ongoing education for ORIC staff.Updates policies and procedures relating to research compliance, ensuring such policies are current and accurate with federal and state regulations. Ensures electronic submission system is in compliance with regulatory requirements. Provides consultation (ORIC staff, committee chairs, committee members, investigators, research staff, etc.) on application of DHHS, FDA and other applicable regulations and statutes for the protection of human subjects to specific research situations. Works to maintain a collaborative relationship to facilitate the shared goal of conducting ethical human research.Assists, advises and guides investigators and research staff on research related regulations, policies and procedures, and guidelines. Advises on issues regarding study development and methodology. Conducts educational and training sessionsconferences with investigators and research staff related to regulations and policies and procedures.Tracks and analyzes key metrics, creates and maintains datasheets, and provides regular reports to Director, ORIC to ensure departmental benchmarks are met.Identifies opportunities for process improvement; and implements and manages quality improvement initiatives to enhance office procedures, IRB performance, biosafety, andor overall human subject's protections.Plans and conducts individual and group training and education programs for new and existing compliance committee members (IRB, IBC, etc.). Participates in research compliance board meetings (IRB, IBC, etc.); tracks member presence to ensure quorum and documents votes.Conducts administrative review and approval of submissions. Provides evaluations and determinations for non-human subject's research, quality improvement, and exempt activities. Assists with the research compliance committees' functions including minutes, agendas, and other correspondence.Develops and maintains a Post-Approval Monitoring Program. Reviews reports and corrective actions. Conducts ongoing education and training or other process improvement initiatives based on the Program's results. Leads preparation and conducts compliance audits, investigations of unanticipated problems or non-compliance, in a thorough and professional manner. Writes reports with corrective actions for the Director, IO, and IRB Chair. Communicates findings with investigators, compliance committees, and appropriate parties and conducts follow-up education and training. Ensures compliance committee membership rosters are compliant with applicable regulatory (OHRP, FDA, OLAW, etc.) requirements and members are up to date with required training and compliant with institutional policies. Participates in annual evaluation of committee chairs and members.Represents ORIC on institutional committees and workgroups which focus on issues relating to research compliance andor human subjects protections.Provides back-up coverage for all regulatory compliance activities not directly assigned.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 and others.Other job functions as assigned.Knowledge, Skills and AbilitiesBachelor's Degree required (in related field) with 5 to 7 years of experience - or master's degree with 3 to 5 years of experience.Minimum of 3 years of research compliance experience in a hospital, university or other research setting. Demonstrated project leadership skills; capable of performing the majority of Assistant Director Responsibilities.Management training andor experience highly desirable.Certification in Research Compliance or similar area required (CIP, CRA, CRP, CCRA, CCRC, etc.) to demonstrate strong working knowledge of federal, state and local regulations pertaining to the conduct of research and research compliance (i.e., DHHS, OHRP, and FDA).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.Candidate must be able to make independent decisions, establish priorities, and react promptly with minimal supervision and a high level of discretion and confidentiality.Demonstrated knowledge of Microsoft Office (Excel, MS-OfficeWORD, ACCESS) and other computer software is required.Benefit StatementFor full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:Medical, dental and vision insuranceEmployer paid group term life and disabilityEmployer contribution toward Health Savings AccountFlexible Spending AccountsPaid Time Off (PTO), Paid Holidays and Paid Parental Leave403(b) with a 5% employer matchVarious voluntary benefitsSupplemental Life, AD&D and DisabilityCritical Illness, Accident and Hospital Indemnity coverageTuition assistanceStudent loan servicing and supportAdoption benefitsBackup Childcare and EldercareEmployee Assistance Program, and other specialized behavioral health services and resources for employees and family membersDiscount on services at Lurie Children's facilitiesDiscount purchasing programThere's a Place for You with UsAt Lurie Children's we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints "” recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.