FDA REGULATED RESEARCH OVERSIGHT PROGRAM COORDINATOR

Job no: 231618-AS
Work type: Staff-Full Time
Department: SMPH/CLINICAL RESEARCH
Location: Madison
Categories: Communications, Editing, Broadcasting, Media, Event Planning, Program Coordination, Grant, Research, Contract Management, Health Care, Medical, Social Services, Office & Administrative Support, Project Management, Quality, Risk Management and Compliance, Research, Scientific



Position Summary:

The FDA Regulated Program Coordinator will provide coordination and support to the Institutional FDA Regulated Oversight Program, Oversight Committee, IND/IDE Consultation Service and IND/IDE and Study Monitoring teams. This position will support required reporting, tracking and document control to ensure that teams are efficient, and all materials meet requirements. This individual will be expected to partner with monitoring teams to provide needed preparation for reviews, and coordinate schedules of monitoring teams and study teams. This individual will also serve as a point of contact for study teams and will assist in directing them to appropriate resources.

The UW School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself and also as a valuable means for eliminating health disparities. As such, we strongly encourage applications from candidates who foster and promote the values of diversity and inclusion.

Position Duties:

List of Duties

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

Degree and Area of Specialization:

Bachelor's Degree required.

Minimum Years and Type of Relevant Work Experience:

Required Experience:
-5 or more years of administrative support experience in a large and complex organization.
-5 or more years of administrative support experience supporting multiple teams or leaders.
-Experience in a research or healthcare organization.

Preferred:
-Experience working with FDA regulated clinical trials.
-Experience working with IND/IDE holders.

Prefix assignment determined by years of relevant work experience.

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.

Department(s):

A532700-MEDICAL SCHOOL/CLINICAL RESEARCH

Work Type:

Full Time: 100%

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $55,000 ANNUAL (12 months)
Depending on Qualifications

Instructions to Applicants:

Please click "" to start the application process. You will be required to submit a cover letter, and resume for consideration. Your cover letter should highlight your experience and skills as they relate to the listed qualifications for maximum consideration.

This application will also require submission of three professional references, including your current or most recent supervisor. References will not be contacted without advance notice.

Contact:

Kim Mcfarlane
kmmcfarlane@wisc.edu
608-263-1130
Relay Access (WTRS): 7-1-1 (out-of-state: TTY: 800.947.3529, STS: 800.833.7637) and above Phone number (See RELAY_SERVICE for further information. )





Official Title:

SR ADMIN PRGM SPEC(R07BN) or ADMIN PROGRAM SPEC(R07DN)

Employment Class:

Academic Staff-Renewable

Job Number:

231618-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/

The University of Wisconsin-Madison is engaged in a Title and Total Compensation (TTC) Project to redesign job titles and compensation structures. As a result of the TTC project, official job titles on current job postings may change in Fall 2020. Job duties and responsibilities will remain the same. For more information please visit: https://hr.wisc.edu/title-and-total-compensation-study/ .

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: Feb 24 2021 Central Standard Time
Applications Close: Mar 10 2021 11:55 PM Central Standard Time