Regulatory Coordinator

The Regulatory Coordinator completes and maintains regulatory documents for clinical trials to ensure protocol, regulatory and Standard Operating Procedures (SOP's) and Good Clinical Practice (GCP) compliance. They will assist the Manager and Supervisor of the unit and train coordinating staff as delegated by the manager. The position requires strong written communications skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information for preparation of documents and assist with responses to IRB and sponsor questions that are compatible with numerous policies and procedures. This position is also responsible for maintaining regulatory compliance guidelines for each trial and educating CERU staff in sponsor guidelines. The incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately in a timely fashion. This position will also include study coordinator duties as time permits which would involve recruiting, screening, assisting in determining eligibility, enrolling study participants, and conducting with a strong focus on teamwork.

• 25% Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee
• 10% Develops clear and accurate informed consent documents
• 10% Maintains complete and accurate regulatory files and records
• 10% 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
• 10% 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
• 20% Study coordination, recruits, screens, selects, determines eligibility, enrolls trial participants, collects complex info, performs medical assessments, answers varied questions under supervision of a medical professional. Performs med assessments.

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Preferred
Bachelor's of Science in biology or health related field.

Required:
-Regulatory experience with emphasis on Human Subject research
-Experience with patient care research visits

Preferred:
-Ophthalmology experience preferred.
-Quality assurance experience preferred

Preferred
Certified Clinical Research Coordinator (CCRC) certification preferred.

Full or Part Time: 80% - 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
Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/).

University sponsorship is not available for this position, including transfers of sponsorship and TN visas. 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.

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, and a document listing contact information for three (3) references, including your current/most recent supervisor. References will not be contacted without prior notice.

Beth Reuter
ejreuter@wisc.edu
608-263-3680
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Regulatory Coordinator(CP085)

A53-MEDICAL SCHOOL/OPHTHAL&VIS SCI/GEN

Academic Staff-Renewable

314060-AS