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.

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

AccountabilityCritical ThinkingWork collaborativelyVerbal and Written CommunicationDetail-orientedPrioritizationTime-managementProficient in MicrosoftWritingRegulatory

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.

Physical Requirements:

Location:

Biorepository

Work City:

Salt Lake City

Work State:

Utah

Scheduled Weekly Hours:

40

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

$26.84 - $42.28

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.