Quality Assurace and Quality Control Specialist

The UW Institute for Clinical and Translational Research (ICTR) provides multidisciplinary investigators with tools, resources, and guidance aimed at accelerating their research findings into practice. ICTR is committed to systematic processes that relentlessly improve translational research quality through continuous improvement. As a national hub for the Clinical and Translational Science Award (CTSA) Program through the NIH National Center for Advancing Translational Sciences (NCATS), ICTR must navigate and effectively respond to the many regulatory requirements for successful submission of grant-related prior approval information. This Quality Assurance and Quality Control Specialist (QA/QC Specialist) will be responsible for assessing, implementing and maintaining formal process improvements related to these regulatory submissions.

This QA/QC Specialist position is housed within the central administration of ICTR and reports to the Director of Program Evaluation. The QA/QC Specialist will serve as a central point for contact with NIH pre-approval regulatory reporting, supporting the ability of ICTR scholars to advance clinical and translational research.

The QA/QC Specialist will provide planning, execution, and monitoring of processes and practices in support of successful regulatory submissions. After identifying and evaluating specific submission process problems, the Specialist will implement interventions to improve efficiency, accuracy, and consistency. The Specialist will enact structured project management techniques that facilitate collaborative processes to ensure expectations are met. This will include working with directors of the Workforce Development team to understand application procedures, review, and selection criteria for KL2 and TL1 scholars, and developing strong and trusting relationships with funding agencies, other QA/QC staff, diverse stakeholders, and ICTR leadership. The outcome of the work will be to contribute meaningfully to the ICTR mission of increasing equity of access to healthcare for all in Wisconsin.

Terminal, 12 month appointment.
This position has the possibility to be extended or converted to an ongoing appointment based on need and/or funding

Qualifications: Skills

Required Qualifications:
-Ability to operate independently and with initiative, with guidance from NCATS and ICTR senior leadership, in a way that provides substantive attention to detail.
-Ability to develop tracking tools and/or instructional materials that facilitate difficult regulatory or other processes.
-Excellent verbal and written communication skills, including strong interpersonal skills to effectively and diplomatically engage ICTR scholars, including ability to use consensus-building and facilitation skills that build trusting relationships.
-Must complete University of Wisconsin-Madison onboarding, IRB training, and other relevant regulatory certifications as needed, with successful re-certifications as necessary and appropriate.
-Proficiency with Microsoft Word, Excel, PowerPoint.

Preferred Qualifications
-Knowledge of NIH research grant principles and regulations (NIH/NCATS Prior Approval Process, clinical research, Human Subjects Research) or familiarity with the CTSA program.
-Proficiency with project management software, cloud-based tools for storing and sharing information.

Qualifications: Experience

Bachelor's degree required, preferably in healthcare related field. Master's or other graduate level degree; OR the equivalent combination of education, training and experience from which comparable skills can be acquired highly preferred.

Required Qualifications:
-Minimum 3 years of experience in project management or Quality Assurance and Quality Control.

Preferred Qualifications
-Experience with project management specifically in the fields of clinical research or healthcare.

Qualifications: Education
Bachelor's degree
How to apply

Please click "Apply Now" on this page 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.

The deadline to apply is January 11, 2021 at 11:55pm CST.

Application Instructions

Please click "Apply Now" on this page 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.

Fixed terminal appointment for one year with opportunity to renew based on funding availability.

The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment.

Questions may be directed to Kim Mcfarlane at kmmcfarlane@wisc.edu and 608-263-1130

The deadline to apply is January 26, 2021 at 11:55pm CST.

Job Type
City

Madison, WI
United States

Last modified
Wednesday, January 27, 2021 - 02:00