Research Regulatory Coordinator II

Job Description:

This position provides subject matter expertise (SME) regarding regulatory research coordination to Intermountain research departments and supports research investigators, managers and directors as needed. The key responsibility of this position is to assure regulatory compliance with the Institutional Review Board (IRB), research sponsors and 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. This position also oversees or coordinates auditing and monitoring of research studies per required regulations and industry best practices.

Work Schedule

• Hybrid role - Position requires on-site presence at times during the week, with flexible scheduling with a minimum of two days per week is required.

• Core business hours: Monday-Friday, 8:00 a.m. - 5:00 p.m. / No weekends or Holidays

Essential Functions

• Research Support: Support various research studies and departments across the Intermountain system, typically working on complex or larger research projects with limited supervision.
• Regulatory Submissions: Prepare and submit regulatory documents, including IRB applications, amendments, monitoring reports, IRB status reports, and continuing reviews. Ensure all study activities comply with regulatory requirements and institutional policies. 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
• Compliance Monitoring: Monitor ongoing studies to ensure compliance with regulatory requirements, report adverse events, protocol deviations, unanticipated problems, and other events per institutional and sponsor reporting policies. Prepares for and participates in internal and external site visits, audits and inspections.
• Record Maintenance: Ensures 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. 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
• Communication & Liaison: Communicate effectively with study sites, regulatory bodies, researchers, study teams, IRBs, sponsors, CROs, and other third parties. Obtain necessary approvals and documentation. Act as a liaison between the research team and regulatory bodies.
• Training & SOP Development: Assist in the training of research staff on regulatory requirements, procedures, and best practices. Provide ongoing education on federal policies and regulations impacting human subject's research. Assists and/or develops and updates departmental Standard Operating Procedures (SOPs) for regulatory processes.
• Protocol Review & Guidance: Review and understand study protocols to ensure compliance with regulatory requirements and guidelines. Provide guidance to research staff on regulatory requirements and best practices. Stays informed about changes in regulatory requirements and guidelines.
• Policy Development & Support: Assist management in developing and executing institutional policies and procedures to ensure compliance with laws and regulations. Support study teams with single patient INDs Emergency Use and compassionate use devices, ensuring compliance with FDA requirements.

Skills

• Computer and application knowledge
• Critical thinking
• Detail oriented
• Collaborative
• Time Management & Prioritization
• Regulatory
• Verbal and Written Communication
• Research
• Documentation
• Independent worker and self-starter

Minimum Qualifications

• 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.
• Demonstrated experience working in a collaborative team environment.
• Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.
• Demonstrated years of experience in a research regulatory role.

Preferred Qualifications

• Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.
• Certified Professional in the field of research or regulatory compliance.
• Experience in a healthcare or hospital setting.

Physical Requirements

• Interact with others by effectively communicating, both orally and in writing.
• Frequent interactions with providers, colleagues, customers, patients/clients and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately.
• Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use for typing, accessing needed information, etc.
• Ongoing need for employee to see and read information, labels, monitors, identify equipment and supplies, and be able to assess customer needs.
• Remain sitting or standing for long periods of time to perform work on a computer, telephone, or other equipment.
• May require lifting and transporting objects and office supplies, bending, kneeling and reaching.
• For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles.

Location:

Intermountain Health Intermountain Medical Center, Intermountain Health St Vincent Regional Hospital, Peaks Regional Office

Work City:

Murray

Work State:

Utah

Scheduled Weekly Hours:

40

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

$30.55 - $48.12

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 package here.

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.

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All positions subject to close without notice.