Research Regulatory Coordinator 1

Research Regulatory Coordinator 1

Requirements

• 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.
• 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 collaboratively in a team environment.
• Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.

Responsibilities

• 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.
• 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.
• Participates in site visits and audits made by sponsors, FDA NIH, or any other agency with regulatory oversight throughout the study.
• 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.
• Monitors regulatory compliance to protocol and audits study documentation to ensure completeness and accuracy of the study records.
• Reviews and/or authors informed consent forms related to research submissions.
• May create forms or complete forms as needed to comply with GCP and FDA standards.
• Coordinates board meetings for IRB Coordinators, obtains quorum, prepares agenda, assigns reviewers, prepares and checks review materials for accurateness and completeness, takes detailed minutes, records committee decisions and votes, and maintains a quorum.
• 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.

Preferred Qualifications

• Regulatory and compliance experience
• Experience in a healthcare or hospital setting