Regulatory Manager

Overview

Job Summary:
The Regulatory Manager provides comprehensive investigator support services for clinical research in the Department of Family Medicine and Community Health at the UW School of Medicine and Public Health (SMPH). This member may oversee and manage regulatory functions and staff. They will provide regulatory support services to investigators conducting research. To carry out these activities, the incumbent will work closely with both the Health Sciences Institutional Review Board (HS-IRB) and the Health Sciences Minimal Risk Institutional Review Board (MR-IRB). This position reports to the Director of Research Operations.

This position is responsible for distilling complex scientific protocols into clear, concise, and accurate clinical research applications, consent forms, and correspondence. Most critical is the ability to manage many detailed projects simultaneously, completing projects in a timely manner, and meeting strict deadlines required by review committees, boards, as well as, by investigators and sponsors of clinical research.

Responsibilities:
Oversees and manages regulatory functions and/or unit staff. Provides regulatory support services to investigators conducting research.

10% Oversees planning, development, implementation, and management of a regulatory office
15% Develops and implements service strategies to meet needs of researchers and staff
5% May exercise supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 FTE or equivalent employees
20% Ensures adherence to all research standards as set forth by all pertinent regulatory agencies
20% Directs regulatory work for a variety of research studies for research teams and investigators
20% Develops and maintains procedures for regulatory document submission and retention processes
10% Oversees the regulatory-related training curriculum for a regulatory team

Education:
Preferred
Bachelor’s Degree

Qualifications:
Required Qualifications:
– Experience with Institutional Review Board (IRB) submissions or equivalent-types of submissions.
– Experience communicating effectively (written and oral) with faculty investigators, research coordinators, sponsors, and staff at all levels.
– Independent problem-solving and analytical skills.
– Ability to manage multiple projects simultaneously.
– Demonstrated attention to detail and time management skills, including experience with accurate and timely documentation.

Preferred Qualifications:
– 2 years of professional experience providing regulatory support services for research studies or equivalent environment.
– Experience with relevant computer software systems and web based programs, including minimum proficiency in Microsoft Office Suite and experience with Application Review for Research Oversight at Wisconsin (ARROW).
– Experience working with human subjects research, grants, scientific writing, health care, and/or working in an academic setting.
– Knowledge of federal human subjects protection regulations.
– Familiarity with obtaining Center for Medicare and Medicaid Services (CMS) approval for research studies.
– In-depth understanding of and/or willing and able to learn about University of Wisconsin administrative policies and procedures as well as applicable state and federal regulations and guidelines.