Position Vacancy ID:
95734-AS

Employment Class:
Academic Staff-Renewable

Working Title:
ClinicalTrials.gov Specialist, Office of Clinical Trials

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

Hiring Department(s):
A530223-MEDICAL SCHOOL/ADMIN/CLINICAL TRIALS

FTE:
100%

Anticipated Begin Date:
OCTOBER 01, 2018

Term:
This is a renewable appointment.

Advertised Salary:
Minimum $45,000 ANNUAL (12 months)
Depending on Qualifications

Degree and area of specialization:
Bachelor's degree required; healthcare or life sciences area preferred.

Minimum number of 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.

License or Certificate:


Position Summary:
The Office of Clinical Trials (OCT) regulatory unit is seeking a ClinicalTrials.gov Specialist to join its team of 20+ staff who provide comprehensive support services to faculty conducting clinical research. Clinical research trials are required to be registered and reported in a publically 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.

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.

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 School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself but, 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.


Additional Information:
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

The School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself but, 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.

Contact:
Staci Andersen
slandersen2@wisc.edu
608-262-3006
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. )

Instructions to Applicants:
Please click on the "Apply Now" 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.

Multiple positions are currently available. By submitting an application for this position, applicants will be considered for each vacancy available.

Additional Link:
Full Position Details

NOTE: A Period of Evaluation will be Required

The University of Wisconsin is an Equal Opportunity and Affirmative Action Employer.

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: Aug 27 2018 Central Daylight Time
Applications Close: Sep 24 2018 11:55 PM Central Daylight Time


To apply please click here!