Research Regulatory Coordinator

Job Description:

Job Essentials

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.
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.
Tracks on an ongoing basis studies and study activities using a searchable database.
Acts as a liaison for study compliance for regulatory documents.
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.
Depending on position within the institution, either reports or receives adverse events.
Depending on position within the institution, reviews and has general understanding of the research protocols in order to ensure site compliance.
Depending on position within the institution, monitors regulatory compliance to protocol and audits study documentation to ensure completeness and accuracy of the study records.
Depending on position within the institution, reviews and/or authors informed consent forms related to research submissions.
Depending on position within the institution, may create forms or complete forms as needed to comply with GCP and FDA standards.
For IRB Coordinators: Coordinates board meetings. Prior to meeting the coordinator obtains quorum, prepares agenda, uses judgment to assign reviewers, prepares and checks review materials for accurateness and completeness. During meeting the coordinator takes detailed minutes (assures minutes comply with OHRP and FDA standards), records committee decisions and votes and maintains a quorum. Post meeting the coordinator communicates committee decisions to researchers in a timely and efficient manner and follows-up on committee actions items.
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.
Prepares for successful audits, as needed.
Ongoing training and education of federal policy and regulations that impact human subjects research and quality assurance requirements
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
Responsible for the development of efficient compliant processes and development of future processes to increase productivity.

Minimum Qualifications

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.
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Five years experience in a regulatory, compliance or research role.
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Experience in a role requiring detailed knowledge of human subject research regulations, strong attention to detail and ability to adhere to policies and procedures.
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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.
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Experience working in a collaboratively in a team environment
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Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.

Preferred Qualifications

Regulatory and compliance experience
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Experience in a healthcare or hospital setting

Physical Requirements:

Interact with others by effectively communicating, both orally and in writing.
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Operate computers and other office equipment requiring the ability to move fingers and hands.
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See and read computer monitors and documents.
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Remain sitting or standing for long periods of time to perform work on a computer, telephone, or other equipment.
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May require lifting and transporting objects and office supplies, bending, kneeling and reaching.

Location:

Work City:

Work State:

Scheduled Weekly Hours:

The hourly range for this position is listed below. Actual hourly rate dependent upon experience.

We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.

Learn more about our comprehensive benefits packages for our Idaho, Nevada, and Utah based caregivers, and for our Colorado, Montana, and Kansas based caregivers; and our commitment to diversity, equity, and inclusion.

Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

All positions subject to close without notice.