CLARiTI Regulatory Coordinator

This position will serve as a regulatory coordinator for a multi-site consortium focused on biomarkers of Alzheimer's disease and Related Disorders (ADRD). The Alzheimer's Disease Research Centers (ADRCs), which are spread across the US and are all centers of excellence in their own research, are now coming together as a consortium to focus on a set of joint objectives that, if successfully achieved, will propel the entire field. The consortium will use advanced brain imaging and fluid biomarkers to identify the multiple causes and their associated temporal characteristics that lead to eventual dementia.

The consortium, headquartered here at UW-Madison, is funded by NIH and will bring resources at an unprecedented scale to the network of ADRCs. The incumbent will be a part of the compliance team that will support 35 external sites in study compliance and monitoring. Job duties include: maintenance of sponsor operations, centralized regulatory support of site regulatory binder, providing guidance to study site teams regarding protocol implementation, regulatory documentation and oversight, review timeliness of data entry, and ensuring FDA IND compliance associated with PET imaging.

Strong attention to detail, verbal and written English language skills, organizational and interpersonal skills are essential. The incumbent will work to optimize program workflows and develop processes in support of the research consortium. Prior experience in team leadership and/or training would be beneficial in this role. A successful candidate will demonstrate their ability to work independently, and as part of a group, using initiative and good judgement on multiple projects simultaneously, prioritizing deadlines and interdisciplinary collaboration. Depending on experience and qualifications, the incumbent may take on a leadership role.

• 10% 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
• 20% Serves as regulatory contact person for research studies involving human subjects
• 20% Maintains complete and accurate regulatory files and records
• 5% Communicates directly with protocol sponsors related to regulatory documents and activities
• 10% Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
• 10% Performs quality checks
• 5% May lead and train other staff
• 15% Contributes to the development of new team and unit processes, procedures, tools, and training

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

Preferred
Bachelor's Degree

Two or more years' regulatory experience in a healthcare or human subject clinical research setting is required. Experience working with FDA IND regulations and requirements is strongly preferred. Experience in team leadership and/or training is helpful but not required.

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.

Ongoing/Renewable

Minimum $60,000 ANNUAL (12 months)
Depending on Qualifications
The expected salary range for this position is $60,000 up to $75,000 for highly experienced candidates. Actual pay will depend on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/).

University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1 STEM OPT Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work.

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.

Erin Chin
echin@medicine.wisc.edu
608-265-3063
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Regulatory Coordinator(CP085)

A53-MEDICAL SCHOOL/MEDICINE/GER-AD DEV

Academic Staff-Renewable

310647-AS