Research Compliance Coordinator / IRB Analyst (REMOTE/Hybrid)
Ann & Robert H. Lurie Children’s Hospital of Chicago
Location: Chicago, Illinois
Type: Full Time
Hospital, Public and Private
4 Year Degree
Telecommuting is allowed.
Internal Number: J2023-3524
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.
Day (United States of America)
Ann & Robert H. Lurie Children's Hospital of Chicago
Provides guidance to investigators and research staff to facilitate the ethical and compliant conduct of research by assisting with questions regarding submission preparation and requirements.
Triages all types of submissions including new studies, amendments, renewals, and incidents (i.e., unanticipated problems).
Conducts regulatory review of research protocol submissions, disclosures, or other research activities for compliance with applicable institutional requirements, state requirements, and federal regulations, and policies.
Substantively interprets applicable federal and state regulations when analyzing research submissions to identify research requirements and/or conduct an in-depth pre-review.
Participates in applicable research compliance board meetings (IRB, IBC, etc.); prepares agenda, records minutes, documents vote, etc.
Provides written reports summarizing findings for review/approval by committee chair(s), study teams, and/or institutional leadership.
Determines appropriate risk categories, exempt and expedited review categories, and other regulatory determinations and requirements (e.g. subpart determinations, IDE/IND determinations, etc.) for studies per all applicable guidelines and regulations (OHRP, OLAW, NIH, FDA. etc.) as part of delegated review and/or before forwarding to committee/chair.
Provides feedback to investigators and research staff to guide them in making necessary modifications to submissions in order to meet applicable institutional, regulatory and other requirements and obtain approval before and after the compliance committee meeting.
Assists in the development and maintenance of compliance programs, including but not limited to departmental policies and procedures, educational/training materials, associated forms, and is responsible for ensuring changes in regulatory and institutional requirements are integrated in draft policies.
Tracks and monitors workload and submissions in order to meet internal and external deadlines and provides regular reports to the Director(s) and Chair(s) upon request.
Participates in compliance audits, post approval monitoring, accreditation applications, government inspections, quality assurance initiatives, site visits and reports as well as other special projects as needed.
Contributes to website development, the development of quality assurance initiatives, as well as other special projects as needed.
Demonstrates desire and initiative to increase knowledge and skills in research compliance by participating in internal/external educational events and research and/or compliance meeting.
Maintains office files in accordance with institutional and regulatory guidelines (OHRP, FDA, etc.). Other duties as assigned.
For 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 insurance
Employer paid group term life and disability
Employer contribution toward Health Savings Account
Flexible Spending Accounts
Paid Time Off (PTO), Paid Holidays and Paid Parental Leave
403(b) with a 5% employer match
Various voluntary benefits:
Supplemental Life, AD&D and Disability
Critical Illness, Accident and Hospital Indemnity coverage
Student loan servicing and support
Backup Childcare and Eldercare
Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
Discount on services at Lurie Children’s facilities
Discount purchasing program
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.
About Ann & Robert H. Lurie Children’s Hospital of Chicago
The mission of Stanley Manne Children’s Research Institute at Ann & Robert H. Lurie Children’s Hospital of Chicago is to generate new knowledge and translate advancements in the prevention, diagnosis, and treatment of diseases that affect children’s health through adolescence and adulthood. Our multidisciplinary teams are committed to making discoveries that will improve the lives of children and their families. Manne Research Institute faculty members investigate a range of children’s health and diseases across the translational science spectrum. The research institute's studies are led by over 750 researchers and staff, and are organized into four scientific pillars: Basic and Preclinical Science; Clinical and Community Trials; Community, Population Health, and Outcomes; and Quantitative Science. Researchers and staff include physicians, scientists, postdocs, coordinators, statisticians, data analysts, trainees, and others who share their expertise. Our pediatricians and scientists routinely collaborate with our academic partner, Northwestern University, and other medical centers and academic institutions across the globe, as well as with community partners such as schools and g...overnments. Manne Research Institute receives more than $80.6 million in external funding annually for research, two-thirds of that from the National Institutes of Health and other federal agencies. It is one of the nation’s premier institutes for pediatric research, investing more dollars and resources in pediatric research than any other area hospital. In addition to clinical and population health research facilities, Manne Research Institute has approximately 125,000 square feet of state-of-the-art laboratory space. The research institute’s wet-lab research is located in the Louis A. Simpson & Kimberly K. Querrey Biomedical Research Building on Northwestern University’s Chicago campus. The building includes wet-bench laboratories, animal facilities, and conference, educational, office, and collaborative space. It is adjacent to Northwestern University research resources and is located one city block from Lurie Children’s.