Research Compliance Coordinator (Hybrid/Remote)

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

• 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.
• Participates in applicable research compliance board meetings (IRB, IBC, etc.); prepares agenda, records minutes, documents vote, etc.
• 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.
• Contributes to website development, the development of quality assurance initiatives, as well as other special projects as needed.
• 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.
• 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.
• Triages all types of submissions including new studies, amendments, renewals, and incidents (i.e., unanticipated problems).
• 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.
• Maintains office files in accordance with institutional and regulatory guidelines (OHRP, FDA, etc.). Other duties as assigned.
• 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.
• 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.
• 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.
• Provides written reports summarizing findings for review/approval by committee chair(s), study teams, and/or institutional leadership.
• Substantively interprets applicable federal and state regulations when analyzing research submissions to identify research requirements and/or conduct an in-depth pre-review.

Knowledge, Skills and Abilities:

• Must possess strong written and verbal communication skills, and be detailed oriented.
• Ability to work in a team-oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
• Must have working knowledge of Windows applications (Excel, MS-Office/WORD, ACCESS).
• Time management skills and the flexibility to accommodate changing priorities in the unit.
• 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, and FDA
• 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.
• Candidate must be able to make independent decisions and function independently with minimal supervision.
• Demonstrated self-discipline and sound, independent judgment completing complex assignments.
• Maintenance of membership in a related professional organization and conference attendance is expected, such as PRIM&R.
• Candidate should be able to function with a high level of discretion and confidentiality.
• 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
• High School Diploma with 3 to 5 years of experience – OR Assoc. Degree /2 years of college with 2 to 4 years exp. – OR Bachelor’s Degree with 1 to 3 years of experience

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:

• Discount on services at Lurie Children’s facilities
• Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
• Tuition assistance
• Adoption benefits
• Discount purchasing program
• Supplemental Life, AD&D and Disability
• Critical Illness, Accident and Hospital Indemnity coverage
• Student loan servicing and support
• Backup Childcare and Eldercare

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]