Institutional Review Board Coordinator - Full Time

Mercy-Health-System-Corporation; Rockford (IL); Hybrid; USD 54,000 - 84,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life & Disability Insurance

FSA/HSA Options

Generous PTO

Job summary

Mercyhealth seeks an IRB Coordinator to provide regulatory expertise and administrative support for the Institutional Review Board overseeing human subject research. The role serves as the primary regulatory resource for investigators and staff, with a hybrid schedule and potential site visits to Mercyhealth locations.

The candidate will educate researchers, review applications for compliance, and prepare IRB documents.

Qualifications

• Bachelor’s degree in biomedical, health science, social sciences or related field.
• Knowledge of federal regulations and guidelines governing human subject research.
• Experience in healthcare or human subject research preferred.
• CIP and GCP certifications required or to be obtained per eligibility.

Responsibilities

• Serve as subject-matter expert and guide researchers on human subject research design and conduct.
• Review new research applications for compliance and required federally mandated elements.
• Communicate items requiring clarification to Principal Investigators and prepare documentation.
• Evaluate reports of unanticipated problems, noncompliance and continuing reviews.
• Prepare agendas, meeting materials and minutes; maintain IRB files.

Skills

Regulatory knowledge

Attention to detail

Excellent written and verbal skills

Problem solving & critical thinking

Education

Bachelor's degree in biomedical/health sciences

CIP certification

GCP certification

Tools

Microsoft Office

Job description

OverviewThe IRB Coordinator provides regulatory expertise, guidance and administrative support to the Institutional Review Board reviewing human subject research protocols. The IRB Coordinator serves as the primary regulatory resource for investigators and staffLocations: Hybrid schedule with ability to visit Mercyhealth locationsSchedule: Monday-Friday, 40 hours/weekShift: DaysEssential Duties and ResponsibilitiesServe as subject-matter expert by educating, consulting and guiding researchers and staff in the design and conduct of human subject research to ensure compliance with federal and state regulations and Mercyhealth policy and standard operating procedures (SOPs)Provides guidance for research investigators and research staff regarding procedural requirements in the processing of research proposalsReviews new research applications for consistency, completeness and compliance with federal and state regulations and institutional guidelinesReview documents for protocol and amendment-specific content and to ensure presence of federally mandated elements of informed consent.Communicate to Principal Investigators items that require clarification or documents required for submission, to complete a research applicationProvide written correspondence that accurately documents the determinations of the IRB and describe any revisions required by the research teamEvaluate reports of unanticipated problems, noncompliance, amendments and continuing review forms and prepare recommendations to the committeeEducate and guide IRB members on the federal and state regulations and Mercyhealth policies and SOPs governing human subject researchAssist in developing, recommending and implementing policies and proceduresMonitor regulatory environment and recommend changes, as needed to IRBPrepare agenda, meeting materials, and minutes and maintain accurate files related to the IRBEducation and ExperienceBachelor's degree in biomedical, health science, social sciences or related field is required.Experience in healthcare or directly related to human subject research is required.Knowledge of the federal regulations and guidelines that govern the conduct of research involving human subjects is required.Moderate level of experience using Microsoft Office products is requiredCertification and LicensureCIP certification required to be obtained and maintained upon meeting eligibility criteriaGCP certification required to obtained and maintained upon meeting edibility criteria.Skills and AbilitiesAbility to interpret and apply laws and regulationsExcellent written and verbal skillsAttention to detail and extensive organization skills.Excellent problem solving, reasoning and critical thinking skillsExcellent typing and word processing skills.Excellent knowledge of spreadsheet and database softwarePosition responsibilities require a high level of independent judgment and has latitude for independent action.Special Physical DemandsThe Special Physical Demands are considered Essential Job Functions of the position with or without reasonable accommodations.While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.Level of SupervisionPerforms under the Manager of Research, Ethics and Chaplaincy.SupervisesThis position has no supervisory responsibilities.PAY RANGE:$54,319.95 - $84,195.93Mercyhealth is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability, or protected veteran status.Mercyhealth offers competitive pay and a comprehensive benefits package including:Medical, Dental, VisionLife & Disability InsuranceFSA/HSA OptionsGenerous, accruing paid time offPaid Parental and caregiver leaveCareer advancement and educational opportunitiesTuition and certification reimbursementCertification ReimbursementWell-being ProgramsEmployee DiscountsOn-Demand PayFinancial EducationAnnual recognition/awards eventsPartner appreciation daysFamily entertainment/attractions discountCommunity service/improvement opportunitiesClick here for more details regarding Mercyhealth Careers Benefit Information.At Mercyhealth, we don’t simply hire people, we empower employee-partners who are passionate about making lives better. As an integrated health system, we deliver exceptional, coordinated across seven hospitals, 85 primary and specialty clinics, and a team of over 7,500 professionals serving northern Illinois and southern Wisconsin.Mercyhealth has been nationally recognized for our commitment to our people and culture, including:#1 in the nation on AARP's Best Employers for Workers Over 50One of Working Mother magazine's 100 Best Companies for Working MothersA Top 50 Company and Top 10 Nonprofit for Executive Women