Job Summary:
The Clinical Research Office (CRO) is seeking a Regulatory Specialist to join its team of 20+ staff who provide comprehensive support services to faculty conducting clinical research. Regulatory unit responsibilities will include working 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.
Clinical research trials are required to be registered and reported in a publicly-accessible database under Section 801 of the Food and Drug Administration Amendments Act (FDAAA). This database is called ClinicalTrials.gov. This position will assist in developing and maintaining support services for research subject to ClinicalTrials.gov requirements. This work will include substantial communication with Principal Investigators (PIs), research coordinators, research nurses, and/or other research team members to register, update and report results.
This position will report to the CRO Operations Integrity Manager and work under the general direction of the CRO Director along with principal investigators for each assigned research study.
The UW School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself and also as a valuable means for eliminating health disparities. As such, we strongly encourage applications from candidates who foster and promote the values of diversity and inclusion.
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.
- 40% Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee
- 20% 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 and Food and Drug Administration (FDA)
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
BS in healthcare or life sciences area preferred.
Qualifications:
Required
-Proficiency in basic computer applications such as Microsoft Office (Word, Excel), e-mail, and internet is necessary
-Knowledge or willingness to learn the following regulations and guidelines: University, State, Food and Drug Administration
(FDA), ClinicalTrials.gov, Good Clinical Practice (GCP) Guidelines, Health Information and Accountability (HIPAA), Code of
Federal Regulations and The Protection of Human Research Subjects
Preferred
-Familiarity and/or experience with UW research infrastructure (e.g., Research and Sponsored Programs, ARROW)
-Comfort in exercising independent discretion
-Ability to work well as part of a team
-Effectiveness building interpersonal working relationships
-Effective oral communication skills
-Dependable, flexible, positive attitude
-Strong analytical skills
-Ability to write in a clear and concise manner
-Attention to detail
-Excellent organization and time management skills
-Ability to simultaneously manage many detailed projects and meet deadlines
-Prior clinical research experience
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 $50,000 ANNUAL (12 months)
Depending on Qualifications
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:
Please click “Apply Now” 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.
Contact:
Jennifer Wilkie
jwilkie@wisc.edu
608-262-8025
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Regulatory Coordinator(CP085)
Department(s):
A53-MEDICAL SCHOOL/ADMIN/CLINICAL TRIALS
Employment Class:
Academic Staff-Renewable
Job Number:
289119-AS