Senior Regulatory Affairs and Research Systems Manager - Pediatrics

University of Chicago•Chicago, IL

17d•Onsite

About The Position

The Senior Regulatory Affairs and Research Systems Manager functions as a leader in the Department’s dynamic clinical research program by managing regulatory and compliance functions for studies conducted in the Department of Pediatrics, overseeing Clinical Trial Management System functionality, and provide expertise in research study conduct. The Senior Regulatory Affairs and Research Systems Manager will have specialized knowledge of regulatory requirements for conducting human subjects research across local and central IRBs; will be responsible for management and oversight of regulatory processes for all Pediatric clinical research programs and projects; and will mentor, guide, and train staff using technical systems. The research projects involve multi-centered cooperative group studies, single-site studies, inter-group studies, grant application and funded studies, industry studies, and investigator-initiated studies. The Senior Regulatory Affairs and Research Systems Manager will be expected to participate in established and future research programs and will serve as the main contact for regulatory purposes requiring interaction with principal investigators, co-investigators, affiliate institutions, sponsoring agents, the Food and Drug Administration (FDA), the Institutional Review Board (IRB), and other regulatory bodies. This role will also be responsible for developing and implementing quality improvement initiatives within the Pediatric Clinical Trials Office. This role will also be the primary liaison with the Divisional Office of Clinical Research for Pediatric representation with Clinical Trial Management Systems.

Requirements

Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

Nice To Haves

Master’s Degree in regulatory affairs, public health, public policy, behavioral science, or a related field.
Experience with cooperative group and industry sponsored FDA regulated clinical trial, and investigator initiated clinical trial site management.
Interacting with local and central IRBs and other regulatory bodies.
Developing and maintaining departmental infrastructure for scientific review, feasibility assessment, and protocol effort projection.
Ensuring compliance of multiple studies with institutional requirements and policies.
Independently developing, or guiding the development of, complex data entry or collection protocols and tools.
Setting objectives , goals, and detailed agendas for multidisciplinary meetings.
Preparing and maintaining FDA regulatory submissions on more than one PI-initiated study overseen by the FDA.
Handling complex situations and/or potential hold issues directly with the FDA, in collaboration with the PI.
ACRP / SOCRA research certification.
Familiarity with electronic regulatory submission platforms and Clinical Trial Management Systems.
Ability to mentors or train others to communicate effectively with CRO and/or sponsor, and in managing and conducting site visits.
Understands the relationship between sites, sponsors and CROs in order to solve problems.
Ability to mentor and train others to ensure that studies are conducted in compliance with institutional requirements and other policies.
Ability to recognize, in complex scenarios, when all types of agreements (MTA, CTA, CDA, DUA, DTA, etc.) are necessary and which procedures to follow, including special terms that may need to be included.
Demonstrates advanced application and knowledge of monitoring and audits.
Trains or leads others in most tasks related to monitoring and audits.
Ability to mentor or train others in meeting preparation and follow up.
Facilitate healthy communication during meetings.
Ability to conduct and document informed consent and assent for multiple interventional and/or complex studies.
Exhibit additional knowledge or skills in consent procedures.
Advanced understanding of sponsor/regulatory reporting.
Ability to implement systems that ensure quality of data and to train others in data collection and entry.

Responsibilities

Oversee Departmental Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out , i ncluding Institutional Review Board (IRB) submission and approval , specialty subcommittee reviews, as well as FDA, IND, and IDE submissions and maintenance.
Participates in planning, development, coordination, and implementation of studies that promote and enhance research collaboration with individuals/groups internal and external to the organization.
Serves as a liaison between principal investigators (PI), co-investigators, sponsoring agents, regulatory bodies, and other members of the research team, leading study teams in meeting internal and external regulatory compliance requirements and serving a vital role during study start-up, monitoring, and audits.
Partner with PI and study team regarding strategic planning around clinical research portfolios.
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors.
Uses specialized expertise to manage compliance documentation submission and maintenance, compliance training, compliance committee formation, and other programmatic functions.
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.
Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research.
Prepares, completes , and submits all compliance documentation on a routine basis.
Coordinates compliance committee meetings.
Plans and executes internal and external audits and activities to support regulatory agency inspections .
Leads and provides expertise in the implementation of compliance activities designated by the University's strategic plans.
Monitors University compliance with regulations and laws.
Represents the University in regulatory proceedings before federal, state and local agencies.
Prepares the University's position statements and responses to information requests.
Leads and manages audit responses and negotiations with administrative agenc ies.
Performs other related work as needed.