Institutional Review Board Coordinator - Full Time

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

FSA/HSA options

Paid time off

Tuition and certification reimburse

Job summary

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

The candidate will educate researchers, review applications for federal and state compliance, communicate required documents, and help maintain IRB records and policies within Mercyhealth's

Qualifications

• Bachelor's degree in biomedical, health science, social sciences or related field is required.

Responsibilities

• Educate researchers and staff on federal/state regulations and Mercyhealth SOPs.
• Guide investigators on procedural requirements for research proposals.
• Review new research applications for completeness and regulatory compliance.
• Communicate items needing clarification or documents for submission.
• Prepare written determinations and describe revisions to research teams.
• Evaluate reports of unanticipated problems, noncompliance, amendments, and continuing reviews.
• Monitor regulatory environment and update IRB policies as needed.
• Prepare agenda, meeting materials, and minutes; maintain IRB files.

Skills

Regulatory interpretation

Written communication

Attention to detail

Analytical thinking

Typing & word processing

Spreadsheet skills

Database software

Education

Bachelor's degree in biomedical, health science, social sciences or related field

Tools

Microsoft Office

Job description

Overview The 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 staff Locations: Hybrid schedule with ability to visit Mercyhealth locations Schedule: Monday-Friday, 40 hours/week Shift: Days Essential Duties and Responsibilities

Essential Duties and Responsibilities

• Serve 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 proposals
• Reviews new research applications for consistency, completeness and compliance with federal and state regulations and institutional guidelines Review 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 application
• Provide written correspondence that accurately documents the determinations of the IRB and describe any revisions required by the research team
• Evaluate reports of unanticipated problems, noncompliance, amendments and continuing review forms and prepare recommendations to the committee
• Educate and guide IRB members on the federal and state regulations and Mercyhealth policies and SOPs governing human subject research Assist in developing, recommending and implementing policies and procedures Monitor regulatory environment and recommend changes, as needed to IRB
• Prepare agenda, meeting materials, and minutes and maintain accurate files related to the IRB

Education and Experience

• Bachelor'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 required.

Certification and Licensure

CIP certification required to be obtained and maintained upon meeting eligibility criteria GCP certification required to obtained and maintained upon meeting edibility criteria.

Skills and Abilities

• Ability to interpret and apply laws and regulations
• Excellent written and verbal skills
• Attention to detail and extensive organization skills.
• Excellent problem solving, reasoning and critical thinking skills
• Excellent typing and word processing skills.
• Excellent knowledge of spreadsheet and database software

Position responsibilities require a high level of independent judgment and has latitude for independent action.

Special Physical Demands

The 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 Supervision

Performs under the Manager of Research, Ethics and Chaplaincy. Supervises This position has no supervisory responsibilities.

PAY RANGE

PAY RANGE: $54,319.95 - $84,195.93

Mercyhealth 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, Vision Life & Disability Insurance FSA/HSA Options Generous, accruing paid time off Paid Parental and caregiver leave Career advancement and educational opportunities Tuition and certification reimbursement Certification Reimbursement Well-being Programs Employee Discounts On-Demand Pay Financial Education Annual recognition/awards events Partner appreciation days Family entertainment/attractions discount Community service/improvement opportunities

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 50
• One of Working Mother magazine's 100 Best Companies for Working Mothers
• A Top 50 Company and Top 10 Nonprofit for Executive Women

For over 135 years, Mercyhealth has provided high-quality health care to residents throughout northern Illinois and southern Wisconsin.

We have a passion for providing comprehensive health care close to home for area residents through our six hospitals and 85 primary and specialty care locations.

As an integrated health system, you can come to us for routine health care, like annual physicals, immunizations and preventive health screenings, as well as highly specialized care, such as neonatal intensive care, heart surgery, stroke care, neurosurgery, cancer treatment and much more.

The range of Mercyhealth's specialties and the skills of our doctors, nurses and clinical staff are truly extraordinary.