Research Compliance Coordinator

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)

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Job Description

Facilitates the ethical conduct of clinical research and ensuring that it is conducted in a manner compliant with all federal, state and local regulations, as well as institutional policies.

Essential Job Functions:

• Provides guidance to investigators and research staff to facilitate the ethical 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 for compliance with applicable federal regulations and federal policies.
• Substantively interprets applicable federal and state regulations when analyzing each submission to conduct an in-depth pre-review.
• Participates in research compliance board meetings (IRB, IBC); prepares agenda, records minutes, documents vote, etc.
• Provides written reports summarizing findings for review/approval by committee chair(s).
• Determines appropriate risk categories, exempt and expedited categories, and other regulatory determinations (e.g. subpart determinations, IDE/IND determinations, etc.) for studies per all applicable regulations (OHRP, OLAW, NIH, FDA. etc.) before forwarding to committee/chair.
• Provides 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
• 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 submissions by maintaining database and providing regular reports to the Director and Chair(s).
• Participates in compliance audits, post approval monitoring, accreditation applications, site visits and reports.
• 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 regulatory guidelines (OHRP, FDA, etc.).
  
  

Knowledge, Skills & Abilities:

• Bachelor’s Degree with 1 years of relevant experience or 6 years of experience in lieu of higher education.
• 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.
• 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.
• Must possess current knowledge of federal, state and local regulations pertaining to the conduct of research and research compliance, such as DHHS, OHRP, and FDA.
• Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
• Maintenance of membership in a related professional organization and conference attendance is expected, such as PRIM&R.
  
  

Education

High School Diploma/GED (Required)

Benefit Statement

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
• Tuition assistance
• Student loan servicing and support
• Adoption benefits
• 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
  
  

There’s a Place for You with Us

At 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.

Support email: [email protected]