Job Summary:
This position provides regulatory and Institutional Review Board (IRB) support services for clinical research being conducted in the UW School of Medicine and Public Health, Department of Surgery. The incumbent will work closely with local UW IRB offices, the Health Sciences Institutional Review Board (HS-IRB), the Minimal Risk Institutional Review Board (MR-IRB) and the UW IRB Reliance team, as well as external IRB agencies, e.g. WCG-IRB and Advarra. This position will also collaborate with UW Carbone Cancer Center (UWCCC)’s Protocol Review and Monitoring Committee (PRMC) and the Research and Development Committee of the William S. Middleton Veterans Hospital (VA Research Committee). Regulatory services include: protocol development, IRB application submissions, essential document maintenance, preparation of FDA documents, and upholding clinical research compliance. This position will also supervise a team of regulatory coordinators and will assist in day-to-day project management of active clinical research projects.
SMPH is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer.
Responsibilities: Provides regulatory support services to investigators conducting research and supervises staff performing similar duties.
- 20% Contributes to the planning, development, implementation, and management of a regulatory office
- 20% Exercises 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 full-time equivalent (FTE) employees
- 10% Ensures adherence to all research standards as set forth by all pertinent regulatory agencies
- 20% Manages, assigns, and performs regulatory work for a variety of research studies for research teams and investigators
- 15% Assists with procedures for regulatory document submission and retention processes
- 5% Provides continuing education and training
- 5% Feasibility Review-Provides feasibility attestation for all Surgery investigators submitting new
IRB applications. - 5% Honest Broker-Review departmental data requests for compliance.
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background – people who as students, faculty, and staff serve Wisconsin and the world.
For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion
Education:
Preferred
Bachelor’s Degreein health care administration, business administration, biological sciences, social
sciences, or other closely related field
Qualifications:
Preferred Qualifications:
– Experience with writing, document analysis and communication skills.
– Two to three years of relevant regulatory experience
– Experience working in human subjects research, grant writing, scientific writing, health care, or
academic setting
– Knowledge of federal human subjects protection regulations
– Prior experience with ARROW and other Institutional Review Board (IRB) application processes
– Experience working on clinical trials
Work Type:
Full Time: 100%
This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum $65,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for the position is $65,000 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/).
Additional Information:
The department will not be able to support a request for a J-1 waiver. If you chose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees.
The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.
How to Apply:
To apply for this position, please click on the “Apply Now” button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience as it relates to this role. You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice.
Contact:
Samantha Connell
slconnell2@wisc.edu
608-265-5311
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Regulatory Supervisor(CP055)
Department(s):
A53-MEDICAL SCHOOL/SURGERY/RESEARCH ADMIN
Employment Class:
Academic Staff-Renewable
Job Number:
288351-AS