Job Summary:
This position will serve as the lead member on the compliance team for a multi-site consortium focused on biomarkers of Alzheimer’s disease and Related Disorders (ADRD). The 37 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 lead the compliance team (3 total, including this role) that will support 37 external sites in study compliance and monitoring. Job duties include: leading the compliance team supervising 2 others, providing guidance to study site teams regarding protocol implementation, providing centralized monitoring of site regulatory compliance, reviewing the timeliness of data entry, and ensuring FDA IND compliance associated with PET scanning.
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.
- 15% 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
- 10% Maintains complete and accurate regulatory files and records
- 5% Communicates directly with protocol sponsors related to regulatory documents and activities
- 5% Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
- 15% Performs quality checks
- 5% May lead and train other staff
- 10% Contributes to the development of new team and unit processes, procedures, tools, and training
- 10% Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 FTE or equivalent employees
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 supervising other professional staff and/or working in a designated team leadership role is preferred. Experience in training and/or education is beneficial.
Strong attention to detail, organizational and interpersonal skills are essential. A successful candidate will demonstrate strong verbal and written English language skills.
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 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:
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.
The Department of Medicine and the University of Wisconsin-Madison are committed to fostering diversity.
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:
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:
286924-AS