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Position Summary: The IRB Coordinator is responsible for coordinating the administrative and regulatory activities of the Institutional Review Board (IRB) to ensure compliance with federal regulations, state laws, institutional policies, and ethical standards governing human subjects research. The IRB Coordinator serves as a resource to investigators, research staff, IRB members, and organizational leadership regarding research protocols, regulatory requirements, and IRB processes.

This position supports the review, approval, monitoring, and documentation of human subjects research activities while promoting the protection of research participants and maintaining institutional compliance with applicable regulatory requirements.

Essential Duties and Responsibilities:

• Coordinate all administrative activities of the Institutional Review Board.
• Manage IRB submissions, protocol reviews, amendments, continuing reviews, closures, and reportable events.
• Perform preliminary reviews of submissions to ensure completeness and regulatory compliance.
• Sort projects into exempt, expedited, or full-board review tracks based on risk level.
• Prepare agenda materials and support documentation for IRB meetings.
• Attend IRB meetings and serve as recording secretary.
• Document meeting minutes and maintain official records of IRB deliberations and actions.
• Communicate IRB determinations, stipulations, and approval notifications to investigators and study teams.
• Monitor protocol expiration dates and ensure timely continuing review activities when required.

• Maintain compliance with applicable federal regulations, including:
  • Department of Health and Human Services (HHS) regulations (45 CFR 46)
  • FDA regulations governing clinical investigations
  • HIPAA Privacy Rule requirements
  • Good Clinical Practice (GCP) standards
  • Institutional policies and procedures
• Review informed consent documents for required regulatory elements.
• Ensure appropriate documentation of IRB actions and retention of regulatory records.
• Maintain Federal wide Assurance (FWA) and other institutional regulatory certifications as applicable.
• Track and manage reportable events, protocol deviations, unanticipated problems, and non-compliance matters.

• Serve as a resource to investigators and research teams regarding IRB requirements, submission processes, and regulatory expectations.
• Provide education and guidance regarding human subjects protection and ethical research practices.
• Assist investigators with preparation and submission of protocols and required documentation.
• Facilitate communication among investigators, sponsors, research personnel, and IRB members.

• Coordinate onboarding and ongoing education for IRB members.
• Assist with development and delivery of educational programs related to human subjects research protections.
• Monitor and track required research-related training and certifications.
• Promote awareness of regulatory updates and institutional policy changes impacting research activities.

• Participate in audits and regulatory inspections.
• Assist with development, implementation, and revision of IRB policies, procedures, and forms.
• Conduct periodic quality assurance reviews of IRB records and processes.
• Support initiatives to improve efficiency, effectiveness, and compliance within the human research protection program.

• Maintain accurate regulatory databases and tracking systems (e.g. IRBNET, CITI, etc).
• Generate reports related to IRB activities, protocol status, approval metrics, and compliance monitoring.
• Prepare information and reports for leadership, committees, auditors, and regulatory agencies as requested.

• Performs additional duties as assigned. As workload permits, may assist the Medical Staff Office with departmental operations, projects, physician onboarding, credentialing-related activities, meeting support, and other administrative functions to support organizational goals.

Qualifications:

• Bachelor's degree in healthcare administration, nursing, life sciences, public health, research administration, or related field.

Preferred

• Experience supporting an Institutional Review Board (IRB).
• Experience with human subjects research and regulatory compliance.
• Knowledge of FDA, OHRP, HIPAA, and Good Clinical Practice requirements.

Certifications Preferred

• Certified IRB Professional (CIP)

Knowledge, Skills, and Abilities

• Knowledge of human subjects research regulations and ethical principles.
• Understanding of IRB operations and review processes.
• Strong organizational and project management skills.
• Excellent written and verbal communication skills.
• Ability to interpret and apply regulatory requirements.
• Strong attention to detail and accuracy.
• Ability to maintain confidentiality and handle sensitive information.
• Proficiency in Microsoft Office applications and research management systems.
• Ability to work independently while effectively collaborating with multidisciplinary teams

Performance Expectations

The IRB Coordinator will be expected to:

• Maintain compliant and timely IRB operations.
• Ensure accurate documentation of IRB activities and decisions.
• Support investigators in meeting regulatory and ethical requirements.
• Promote protection of human research participants.
• Contribute to regulatory readiness and successful audits or inspections.
• Foster collaboration among research teams, IRB members, and organizational leadership.

Work Shift Details:

Department:

At Silver Cross Hospital, we care about your health and well-being and that is why we work hard to provide quality and affordable benefit options for you and your eligible family members.

Silver Cross Hospital and Silver Cross Medical Groups offer a comprehensive benefit package available for Full-time and Part-time employees which includes:

Medical, Dental and Vision plans

Life Insurance

Flexible Spending Account

Other voluntary benefit plans

PTO and Sick time

401(k) plan with a match

Wellness program

Tuition Reimbursement

Registry employees who meet eligibility may participate in our 401(k) Savings plan with a potential match. However, registry employees are ineligible for Health and Welfare benefits.

The expected pay for this position is listed below:

The final pay rate offered may be more than the posted range based on several factors including but not limited to: licensure, certifications, work experience, education, knowledge, demonstrated abilities, internal equity, market data, and more.