CLARiTI Regulatory Coordinator

Job Summary :

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.

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.

• 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

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 :

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.

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 $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 ().

Additional Information :

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.

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.

Contact : Erin Chin

echin@medicine.wisc.edu

608-265-3063

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 : 310647-AS

The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here

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 :

Employment may require a criminal background check. It may 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).

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Salary : $60,000 - $75,000