Job Description

University of Utah Job Description

Job Summary

Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.

Qualifications

Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency required; demonstrated human relations and effective communication skills also required.

One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Essential Functions

1. Supports all aspects of regulatory compliance.
2. Prepares regulatory documents, including consent forms for submission to research review committees.
3. Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
4. Tracks study approvals and expirations to ensure uninterrupted project approval.
5. Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB).
6. Submits study renewal applications and study progress reports to the IRB.
7. Coordinates with study sponsor, investigator and IRB to complete study closure activities.
8. Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission.
9. Recommends and implements regulatory process improvements.
10. Maintains current knowledge of federal and institutional guidelines and requirements governing research.
11. Maintains regulatory database.
12. Generates ad hoc reports as requested.

Problem Solving

This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.

Comments

This position requires a sophisticated understanding of regulatory requirements. The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and follow-through.

Work Environment and Level of Frequency typically required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking. 

Seldom: Bending, reaching overhead.

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit.  The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient's status and provide care as described in the department's policies and procedures manual.