Job Description

University of Utah Job Description

Job Summary

Independently utilizes experience and expertise to accurately and efficiently manage the submission of regulatory documents to ensure compliance with governing requirements. Offers mentorship and training to new and junior staff and assists in the development of procedures and policies. Manages complex and non-routine regulatory functions. Responsible for making independent decisions regarding protocol issues and resolving protocol deviations.

Qualifications

Bachelor’s degree in a research or related area plus four years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required.

Three years of regulatory experience, an understanding of medical terminology and technical writing experience required.

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. Prepares and ensures submission of appropriate documents to the IRB , including new study applications, continuing reviews, amendments, informed consent, revisions, adverse events, and report forms.
2. Prepares and facilitates advanced regulatory submissions, including IND and/or IDE applications and reports.
3. Analyzes and mitigates complex, non-routine regulatory issues and workflow problems. Acts as a liaison between the University parties (PI, regulatory team, study team, etc.) and study sponsors and/or regulatory agencies on all issues pertaining to regulatory compliance. Serves as a resource to the clinical research staff on advanced regulatory issues and concepts. 
4. Addresses and resolves complex regulatory matters with industry sponsors and affiliates by defending local policies and upholding compliance.
5. Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates.
6. May act as a lead regulatory team member by managing regulatory work portfolio and assigning tasks to other members of the regulatory team.
7. Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations, including complex protocol, multi-site trial and IND/IDE issues.
8. Offers mentorship and training to new and junior staff. Creates educational content to facilitate such training and mentorship.

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.