REGULATORY RESEARCH SPECIALIST


REGULATORY RESEARCH SPECIALIST

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Job no: 269630-AS
Work type: Partial Remote, Staff Full or Part Time, Staff-Full Time, Staff-Part Time
Department:SMPH/NEURO SURG/NEURO SURG

Location: Madison
Categories: Institutional Audit and Compliance

Job Summary:

The Department of Neurological Surgery is looking for a Regulatory Specialist to provide regulatory and research support services to the department’s expanding research program(s). Under the direction of the Research Administrator, the incumbent will join a fast-paced, clinical research environment. The incumbent will work independently, and as part of a group, using initiative and good judgment on multiple projects simultaneously, prioritizing deadlines and interdisciplinary collaboration. The incumbent must demonstrate excellent oral and written communication skills, attention to detail and strong organizational skills.
SMPH is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer. Applications from Black, Indigenous and People of Color (BIPOC) individuals, LGBTQ+ and non-binary identities, women, persons with disabilities, military service members and veterans are strongly encouraged.

Responsibilities: Assists in all regulatory activities including reviewing documents, applications, and reports and ensuring compliance with internal and external regulatory framework.
  • 20% Ensures compliance with all regulations and laws pertaining to unit’s business
  • 20% Compiles and maintains appropriate documents for regulatory submissions
  • 20% Conducts research to support regulatory submissions
  • 20% Prepares and submits documentation to regulatory agencies
  • 15% Assists the Research Administrator with pre/post award activities
  • 5% May assist with training of staff
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 Degree in biological sciences, health care or related field preferred.

Qualifications:

Preferred, but highly desirable:
– Experience with Human Subjects (IRB), Biosafety (IBC), and/or Animal (IACUC) protocols/submissions
– Experience with human subjects research
– Experience with pre- and post-award grant submissions
– Experience with MTAs, agreements, contracts and the shipping of biological materials
– Experience with relevant software systems such as REDCap, ARROW, other electronic IRB systems, OnCore, or HealthLink, Microsoft Office Suite, Adobe Acrobat, and file-sharing systems such as Google Drive or Box
Additional Knowledge, Skills & Abilities:
– Effective oral and written communication skills, independent problem solving and analytical skills, and attention to detail
– Excellent organizational and prioritizations skills
– Knowledge and commitment to advance inclusion, diversity, equity, access, and anti-racism in all aspects of the department’s research endeavors
– In-depth understanding of research clinical principles and study guidelines
– Ability to manage multiple projects
– Ability to effectively support investigators and study teams with a service-oriented approach

Work Type:

Full or Part Time: 80% – 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 $43,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for the position is $43,000, 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 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.
This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.
Effective January 1, 2020, the U.S. Department of Labor Fair Labor Standards Act (FLSA) will be updated to require that positions earning less than $35,568 annually be considered non-exempt under FLSA provisions for overtime (see https://www.dol.gov/whd/overtime2019/ ). Based on these rules, if the person selected for this recruitment will earn less than the new salary threshold at January 1, 2020 ($35,568 annually), he/she will be an academic staff non-exempt employee, will be paid hourly, and will receive overtime compensation for any hours worked over 40 in a workweek.

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 relevant to the position. 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:

Brittany Huser
bhuser@wisc.edu
608-265-2978
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Regulatory Specialist(CP051)

Department(s):

A535700-MEDICAL SCHOOL/NEURO SURG/NEURO SURG

Employment Class:

Academic Staff-Renewable

Job Number:

269630-AS

The University of Wisconsin is an Equal Opportunity and Affirmative Action Employer. We promote excellence through diversity and encourage all qualified individuals to apply.
If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/
Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).
The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department .

Applications Open: Oct 28 2022 Central Daylight Time
Applications Close: Nov 11 2022 11:55 PM Central Standard Time

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