Research Compliance Coordinator

at Ann & Robert H. Lurie Children's Hospital of Chica in Lake Forest, Illinois, United States

Job Description

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)

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

Job Description
Facilitates the ethical conduct of research and ensuring that it is conducted in a manner compliant with all federal, state and local regulations, as well asinstitutional policies. Position may be assigned to one or more program areas within the 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.

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.

Knowledge, Skills and Abilities:

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

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.

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.

Candidate should be able to function... For full info follow application link.

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