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

Assists the Director and Staff of the Office of Research Integrity and Compliance (ORIC) in promoting 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 direct feedback to investigators and research coordinators to guide them regarding IRB submission preparation and requirements. Conducts educational and training sessions/conferences with investigators and research staff related to regulations and policies and procedures.Conducts regulatory review of initial, continuing and amended 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.   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 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.Prepares for and participates in research compliance board meetings (IRB and IBC); agenda preparation, recording minutes, preparing meeting reviews and written follow-up reports/correspondence to investigators.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. Helps develop databases, entering, tracking and monitoring submissions.  Assists in the development and implementation of a Post-Approval Monitoring program. Conducts Post-Approval Monitoring reviews following a checklist, drafts reports with findings and recommended actions. Utilizes findings as a means to identify training opportunities or areas in need for process improvement.Coordinates and conducts formal training of ORIC staff. Assists in the preparation and conduct of compliance audits, accreditation applications, site visits and reports.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.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.).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.

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Knowledge, skills & abilities:

Bachelor’s Degree with 5 years of relevant experience or 10 years of experience in lieu of higher education. Experience must include 1 year of 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.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 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.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

Bachelor's Degree

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: candidatesupport@luriechildrens.org