Regulatory Coordinator

The UW-CTI is seeking a dependable and flexible Clinical Trials Regulatory Coordinator with a positive attitude to join its team to help provide comprehensive support services to faculty conducting clinical research. The ideal candidate is organized, detail-oriented, analytic, and works well in a multi-disciplinary team with minimal supervision to achieve a common goal. In addition demonstrates strong knowledge of following regulations and guidelines: University, State, FDA, ClinicalTrials.gov, Good Clinical Practice (GCP) Guidelines, Health Information and Accountability (HIPAA), Code of Federal Regulations and The Protection of Human Research Subjects. This position will work closely with investigators, research coordinators, industry sponsors, contract research organizations and others to coordinate the preparation of documents necessary to obtain and maintain protocol approval from various Institutional Review Boards (e.g., UW Health Sciences, commercial, VA) and research oversight bodies. Excellent time management and verbal and written communication skills are imperative.

• 40% Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee
• 15% Develops clear and accurate informed consent documents
• 5% Serves as regulatory contact person for research studies involving human subjects
• 5% 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
• 5% Performs quality checks
• 5% May lead and train other staff
• 5% Contributes to the development of new team and unit processes, procedures, tools, and training
• 5% Develops, prepares, and submits compassionate use application materials to regulatory bodies such as the Institutional Review Board (IRB) and Food and Drug Administration (FDA)
• 5% Audits and serves as a subject matter expert and point of contact for potentially affected units and affiliated organizations, ensuring appropriate notices are issued relating to compliance

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 in a health or science related field

Required
- Proficiency in basic computer applications such as Microsoft Office (Word, Excel, Email)

Preferred
- Familiarity and/or experience with UW research infrastructure (e.g., Research and Sponsored Programs, ARROW)
- Prior clinical research experience

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 $51,955 ANNUAL (12 months)
Depending on Qualifications
The starting salary for this position is $51,955 but is negotiable based on experience and qualifications.

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. If you are selected for this position you must provide proof of work authorization and eligibility to work.

Work experience should demonstrate dependability, flexibility, and maturity. Candidates must be effective at building interpersonal relationships with constructive interactions, be clear and effective communicators, promote and create collegial environments that value accountability.

TB testing and a Caregiver Background Check will be required at the time of employment. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial Caregiver Check to be eligible for employment under the Wisconsin Caregiver Law and then every four years.

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.

Jennifer Wilkie
jwilkie@wisc.edu
608-262-8025
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Regulatory Coordinator(CP085)

A53-MEDICAL SCHOOL/CLINICAL RESEARCH

Academic Staff-Renewable

314413-AS