PSTO Sr Regulatory Coordinator

PSTO Sr Regulatory Coordinator

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.

Preferred Qualifications

• 2-3 years of regulatory experience, an understanding of medical terminology and technical writing experience preferred.
• Oncology clinical trial experience highly preferred.
• Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines.
• Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.
• Strong attention to detail, establishing priorities, and adhering to deadlines.
• Able to show initiative and work independently, take initiative and complete tasks to meet deadlines.
• Excellent interpersonal communication (including oral and written) and leadership skills also required.
• Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools.
• SOCRA or ACRP certification.

Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve - which includes Idaho, Montana, Nevada, Utah, and Wyoming - with impact worldwide.
In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute's mission and this position.

Responsibilities
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.

Minimum 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 not responsible for providing patient care.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences


Special Instructions


Requisition Number: PRN39752B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01345 - HCI Clinical Resrch Compliance
Location: Campus
Pay Rate Range: 22.88 to 43.46
Close Date:
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/170648


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