Research Regulatory Coordinator

Intermountain Healthcare Inc.; Murray (UT); Híbrido; USD 39.000 - 61.000; Jornada completa

Descripción de la vacante

Intermountain Health is seeking a Regulatory Research Coordinator to support IRB/regulatory submissions and ensure adherence to GCP/ICH guidelines across multi-site studies.

The role emphasizes coordination with investigators, study staff, and regulatory bodies, with hybrid on-site requirements for training and meetings. A strong regulatory background and collaborative mindset are essential for success.

Formación

• Experience in regulatory/compliance roles in healthcare or research.
• Familiarity with IRB processes, GCP and ICH guidelines preferred.
• Strong written and verbal communication skills for cross-functional teams.
• Ability to coordinate regulatory submissions and maintain documentation in multiple systems.

Responsabilidades

• Assist in preparation, submission, and review of regulatory documents including IRB applications.
• Monitor ongoing studies for regulatory compliance and report deviations.
• Maintain regulatory documents and audits readiness for regulatory bodies.
• Communicate with study sites, IRBs, sponsors, CROs and other stakeholders.
• Assist in training staff on regulatory requirements and procedures.

Conocimientos

Accountability

Critical Thinking

Work collaboratively

Verbal and Written Communication

Detail-oriented

Prioritization

Time-management

Proficient in Microsoft

Writing

Regulatory

Educación

Bachelor's Degree in a clinical or life science field

Descripción del empleo

Intermountain Health Intermountain Medical Center

Full time

R179755

Job Description

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.

Join our research team as a Regulatory Research Coordinator , where you’ll play a key role in supporting investigators and research leaders while helping ensure the highest standards of regulatory compliance and protection for research participants. This position coordinates IRB and regulatory activities in accordance with sponsor, federal and state requirements, Good Clinical Practice (GCP), and ICH guidelines.

We’re looking for a collaborative, self-motivated professional who can work effectively both independently and as part of a team. Experience with IRB/regulatory submissions, physician investigators, or coordinating-center activities is highly valued.

This position supports a multi-year, grant-funded research project, with continued employment anticipated for the duration of the project and contingent upon ongoing grant funding and project needs.

Work Schedule

• Hybrid role – Position requires on-site presence at times for training and meetings.
• Core business hours: Monday–Friday, 8:00 a.m. – 5:00 p.m.

Essential Functions

• Research Coordination: Assist in the preparation, submission, and review of regulatory documents, including IRB applications, amendments, and single IRB submissions for multi-site studies. Ensure all study activities comply with regulatory requirements and institutional 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.
• 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: Communicate effectively with study sites, regulatory bodies, researchers, study teams, IRBs, sponsors, CROs, and other third parties. Acts as liaison to study teams to obtain necessary approvals and documentation.
• Training Support: 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.
• Meeting Coordination: Schedule and coordinate meetings related to study and regulatory compliance. Participate in site visits and audits conducted by sponsors, FDA, NIH, or other regulatory agencies.
• Document Management: Assist in drafting, reviewing, and maintaining informed consent documents to ensure they meet regulatory standards. Create forms and templates or complete forms as needed to comply with GCP and FDA standards.
• Regulatory Updates: Stay informed about changes in regulatory requirements and guidelines. Assist management in developing and executing institutional policies and procedures to ensure compliance with federal, state, and local laws and regulations related to research.

Skills

• Accountability
• Critical Thinking
• Work collaboratively
• Verbal and Written Communication
• Detail-oriented
• Prioritization
• Time-management
• Proficient in Microsoft
• Writing
• Regulatory

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

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 employees 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

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.

$28.06 - $44.20

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 (https://intermountainhealthcare.org/careers/benefits) .

By applying for a position with Intermountain, I acknowledge that I will comply with all applicable Intermountain policies and expectations. If applying for a remote or hybrid role, this includes remote work expectations related to confidentiality, information security, work schedules, conflicts of interest, and use of company equipment. I further acknowledge that outside employment or activities may not interfere with job responsibilities or create a conflict of interest with Intermountain. Actual or reasonably perceived conflicts may be grounds for disqualification from consideration or, if hired, corrective action up to and including termination of employment.

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.

At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process.

All positions subject to close without notice.

Headquartered in Utah with locations in six primary states and additional operations across the western U.S., Intermountain Health is a nonprofit system of 34 hospitals, 400+ clinics, a medical group of more than 4,800 employed physicians and advanced care providers, a health plan division called Select Health with more than one million members, and other health services. Helping people live the healthiest lives possible, Intermountain is widely recognized as a leader in clinical quality improvement and efficient healthcare delivery.

Join our world-class team and embark on a career filled with opportunities, strength, innovation, and fulfillment.

Intermountain Health’s PEAK program supports caregivers in the pursuit of their education goals and career aspirations by providing up-front tuition coverage paid directly to the academic institution. The program offers 100+ learning options to choose from, including undergraduate studies, high school diplomas, and professional skills and certificates. Caregivers are eligible to participate in PEAK on day 1 of employment. Learn more. (https://intermountainhealthcare.org/careers/working-for-intermountain/employee-benefits/peak-program/)

The primary intent of this job description is to set a fair and equitable rate of pay for this classification. Only those key duties necessary for proper job evaluation and/or labor market analysis have been included. Other duties may be assigned by the supervisor.

All positions subject to close without notice.

Thanks for your interest in continuing your career with our team!