Job Summary:
This position within the Alzheimer’s Disease Research Center (ADRC) at UW Madison will lead the regulatory activities for multiple center-wide research initiatives and is responsible for fulfilling regulatory responsibilities for the center. In addition, this position will serve as a subject matter expert providing regulatory leadership, training, and consultation to staff and investigators in ADRC and to the many affiliated studies/labs/teams.
As the regulatory leader, this position will fulfill the following regulatory duties (including but not limited to):
– Manage clinical research protocols, applications, and amendments for submission for the IRB for center-wide initiatives
– Partner with investigators and staff to assess regulatory feasibility of new studies and manage regulatory study start-up for new projects
– Submit serious adverse event reports, unanticipated problems, protocol deviations, and other reports required by the IRB
– Serve as a liaison with the IRB to address questions and help facilitate IRB approval
– Serve as a member of the ADRC resource request team assessing regulatory risk and feasibility for requests to use ADRC resources internally and externally
In addition to completing the necessary regulatory duties, this position will be a subject matter expert point of contact for ADRC and ADRC-affiliated investigators and staff and will provide training and consultation regarding regulatory topics such as IRB submissions, consenting, protocol compliance, adverse event reporting, etc. to ADRC and affiliated staff and investigators.
This position will report to the ADRC Executive Administrator and will be part of the ADRC Administrative Core (core A). Beyond the duties described, this position will have opportunities to identify and lead or participate in regulatory related initiatives. In partnership with the Administrative team, the incumbent will provide operational support in initiatives to help drive the growth and performance of the ADRC.
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 for research studies. Assists in all regulatory activities including reviewing documents, applications, and reports, and ensuring compliance with the internal and external regulatory framework. Ensures compliance with all regulations, laws, and research standards pertaining to research. Applies skills to a broad range of different types of studies, navigates resources, and identifies issues needing escalation. Performs quality checks and may train staff. Contributes to the development of new team and unit processes, procedures, tools, and training.
- 20% Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee
- 5% Develops clear and accurate informed consent documents
- 5% Serves as regulatory contact person for research studies involving human subjects
- 10% Maintains complete and accurate regulatory files and records
- 5% Communicates directly with protocol sponsors related to regulatory documents and activities
- 20% Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
- 5% Performs quality checks
- 5% May lead and train other staff
- 5% Contributes to the development of new team and unit processes, procedures, tools, and training
- 20% Provides support to the Administration team on special projects as assigned
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
Qualifications:
Required:
– At least two years of regulatory experience with human subjects research
Preferred qualifications:
– Experience in an academic medical center or academic clinical research setting
– Experience in IRB submissions at UW Madison
An ideal candidate will be:
– Detail oriented
– Able to consistently deliver high quality, accurate, and compliant work
– Organized and have excellent time management abilities
– Independent and self-motivated with strong interpersonal skills
Work Type:
Full or Part Time: 50% – 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 $60,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for this position is $60,000; however, we anticipate the hiring range to be $60,000 – $75,550 depending 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 (http://hr.wisc.edu/benefits/).
Additional Information:
We anticipate that this position will be filled at 50% FTE initially. There may be opportunities for the position to increase FTE, potentially up to 100% FTE, based on future needs.
Effective January 1, 2020, the U.S. Department of Labor Fair Labor Standards Act (FLSA) was 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.
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:
At UW School of Medicine and Public Health, we are dedicated to building a diverse, inclusive and authentic workplace, so if you’re excited about this role, we encourage you 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:
Nicole Smialek
nsmialek@medicine.wisc.edu
608-265-3745
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Regulatory Coordinator(CP085)
Department(s):
A53-MEDICAL SCHOOL/MEDICINE/GER-AD DEV
Employment Class:
Academic Staff-Renewable
Job Number:
287966-AS