Senior Research Compliance Coordinator / IRB Analyst (REMOTE/Hybrid)
Lurie Children's Hospital @ Chicago
Location: Chicago, Illinois
Type: Full Time
Academic Medical Group
Health Care System
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.
Support email: email@example.com
4 Year Degree
Telecommuting is allowed.
Internal Number: JR2022-3111
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.
Facilitates the ethical conduct of clinical research and ensures that it is conducted in a manner compliant with all federal, state and local regulations, as well as institutional policies. Position may be assigned to one or more program areas within Office of Research Integrity and Compliance, including but not limited to human subjects research (Institutional Review Board), Institutional Biosafety, conflicts of interest, export controls, and/or quality assurance.
Area Specific Job Accountabilities:
Provides guidance to investigators and research staff to facilitate the ethical and compliant conduct of research by assisting with questions regarding IRB submission, preparation, and requirements.
Triages all types of IRB 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 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 categories, and other regulatory determinations and requirements (e.g. subpart determinations, IDE/IND determinations, etc.) for studies per all applicable regulations (OHRP, OLAW, NIH, FDA. etc.) as part of delegated review and/or before forwarding to committee/chair.
Provides direct feedback to investigators and research coordinators 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 implementation 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 committees.
Maintains office files in accordance with regulatory guidelines (OHRP, FDA, etc.).
Initiates and participates in the development and maintenance of compliance programs, educational/training materials, associated forms and policies, and is responsible for ensuring changes in regulatory and institutional requirements are integrated in draft policies.
Coordinates and conducts formal training of ORIC staff.
Identifies areas for process and quality improvement, including modifying reviewer checklists, updating electronic submission applications, website improvements and development.
Regularly reviews that the electronic submission system is in compliance with regulatory requirements.
Assures standards of required accrediting agencies (AAHRPP, etc.) are achieved and maintained.
Other duties as assigned.
In-person attendance may be required as frequently as once monthly or on a quarterly basis for staff meetings.
Knowledge, Skills and Abilities:
High School Diploma with 5 to 7 years of experience, or Assoc. Degree/2 years of college with 4 to 6 years of experience or bachelor’s degree with 3 to 5 years of experience.
Minimum to include 2 years of clinical research compliance experience. Certification in Research Compliance or related area preferred (i.e., CRA, CRP, CCRA, CCRC, CIP, etc.) to demonstrate a thorough knowledge of FDA, DHHS, and/or other applicable regulatory requirements.
Candidate must be able to make independent decisions and function independently with minimal supervision. Candidate should be able to function with a high level of discretion and confidentiality. Ability to work in a team-oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction. Time management skills and the flexibility to accommodate changing priorities in the unit.
Demonstrated self-discipline and sound, independent judgment completing complex assignments. Ability to work in high-volume, high-pressure and fast paced environment to manage and prioritize a large task list with deadlines and competing priorities.
Must possess strong written and verbal communication skills and be detailed oriented. 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.
Must possess and maintain current knowledge of federal, state and local regulations and policy pertaining to the conduct of research and research compliance, such as DHHS, OHRP, FDA, OLAW, and USDA.
Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
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.