REGULATORY SPECIALIST, OFFICE OF CLINICAL TRIALS

Job no: 231924-AS
Work type: Staff Full or Part Time, Staff-Full Time, Staff-Part Time
Department: SMPHADMINCLINICAL TRIALS
Location: Madison
Categories: Communications, Editing, Broadcasting, Media, Health Care, Medical, Social Services, Laboratory Technician, Research Specialists, Project Management, Quality, Risk Management and Compliance, Research, Scientific, Training, Employee Development



Position Summary:

The Office of Clinical Trials (OCT) 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 (CROs) 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 OCT Operations Integrity Manager and work under the general direction of the OCT 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.

Position Duties:

List of Duties

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

Degree and Area of Specialization:

Bachelor's degree required; healthcare or life sciences area preferred.

Minimum Years and Type of Relevant Work Experience:

-A minimum of one year of relevant experience required; 2+ years clinical research experience preferred.
-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.
-Familiarity and/or experience working with UW research infrastructure (e.g., Research and Sponsored Programs, ARROW) highly desirable.

Ideal candidates will possess the following attributes:
-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

Prefix assignment determined by years of relevant work experience.

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.

Department(s):

A530223-MEDICAL SCHOOL/ADMIN/CLINICAL TRIALS

Work Type:

Full or Part Time: 80% - 100%

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $50,000 ANNUAL (12 months)
Depending on Qualifications

Instructions to Applicants:

Please click on the "" button to start the application process. Please upload a resume and cover letter. In your cover letter, please address your experience with the knowledge and skills of the position. You will also be asked to provide three professional/supervisor references during the application process.

Contact:

Kim Mcfarlane
kmmcfarlane@wisc.edu
608-263-1130
Relay Access (WTRS): 7-1-1 (out-of-state: TTY: 800.947.3529, STS: 800.833.7637) and above Phone number (See RELAY_SERVICE for further information. )





Official Title:

SR ADMIN PRGM SPEC(R07BN) or ADMIN PROGRAM SPEC(R07DN) or ASSOC ADMIN PRGM SPEC(R07FN)

Employment Class:

Academic Staff-Renewable

Job Number:

231924-AS

The University of Wisconsin is an Equal Opportunity and Affirmative Action Employer. We promote excellence through diversity and encourage all qualified individuals to apply.

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: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/

The University of Wisconsin-Madison is engaged in a Title and Total Compensation (TTC) Project to redesign job titles and compensation structures. As a result of the TTC project, official job titles on current job postings may change in Fall 2020. Job duties and responsibilities will remain the same. For more information please visit: https://hr.wisc.edu/title-and-total-compensation-study/ .

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

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department .

Applications Open: Mar 3 2021 Central Standard Time
Applications Close: Mar 17 2021 11:55 PM Central Daylight Time