Research Regulatory Coord - LDS Hospital
Job Number 143929
The purpose of this position is to provide regulatory research coordination to Intermountain research departments and to support research investigators, managers and directors as needed. The key responsibility of this position is to assure regulatory compliance with Institutional Review Board (IRB), sponsor, federal and state regulations pertaining to the protection of human subjects participating in research as according to Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.
Entry Rate: $19.48
Benefits Eligible : Yes
Shift Details: This is a full-time, benefits-eligible position. Must be available to work 40 hours per week. Shifts will be Monday through Friday, 8:00 a.m. to 4:30 p.m.
Job duties may include, but are not limited to:
1.Coordinates and performs the responsibilities related to research applications (new, ongoing and continuing) including IRB and Privacy reviews of research submissions. Uses judgment to determine if projects are compliant with federal research regulations and Intermountain policies. Contacts and advises study staff and investigators in the preparation and completion of submissions.
2. Maintains study records: application(s), study approval(s) and other relevant study documentation and information up to date and in compliance with federal, state and institutional requirements. Maintains up to date files (paper and electronic) of all regulatory documents and correspondence. The incumbent is also responsible for meeting with auditors and monitors reviewing regulatory files as requested and/or required on an ongoing basis and/or during the conduct of the clinical investigations.
3. Tracks on an ongoing basis studies and study activities using a searchable database.
4. Acts as a liaison for study compliance for regulatory documents.
5. Depending on position within the institution, participates in site visits and audits made by sponsors, FDA NIH, or any other agency with regulatory oversight throughout the study.
6. Depending on position within the institution, either reports or receives adverse events.
7. Depending on position within the institution, reviews and has general understanding of the research protocols in order to ensure site compliance.
8. Depending on position within the institution, monitors regulatory compliance to protocol and audits study documentation to ensure completeness and accuracy of the study records.
9. Depending on position within the institution, reviews and/or authors informed consent forms related to research submissions.
10. Depending on position within the institution, may create forms or complete forms as needed to comply with GCP and FDA standards.
11. Communicates effectively with researchers, study teams, and IRBs. Provides education and direction regarding the fundamentals of human subject research, Intermountain IRB/Research policies, procedures, and guidelines, and federal and state regulations.
12. Prepares for successful audits, as needed.
13. Ongoing training and education of federal policy and regulations that impact human subjects research and quality assurance requirements
14. Assists management with the development and execution of institutional policies and procedures to ensure Intermountain Healthcare compliance with Federal, State and local laws and regulations related to research
15. Responsible for the development of efficient compliant processes and development of future processes to increase productivity
Bachelor’s degree plus one year of experience in a regulatory, compliance or research role. (Degree must be obtained through an accredited institution. Education is verified.) Or, five years experience in a regulatory, compliance or research role.
Experience in a role requiring detailed knowledge of human subject research regulations, strong attention to detail and ability to adhere to policies and procedures.
Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills: Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
Experience working in a collaboratively in a team environment
Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.
CCRP, ACRP, or CIP Certification highly preferred
Regulatory and compliance experience
Experience in a healthcare or hospital setting
Speaking, hearing / listening, seeing, manual dexterity
All positions subject to close without notice
Intermountain Healthcare is an equal opportunity employer M/F/D/V
Job Type: Full Time
Location: Salt Lake City, UT, US