[Hiring] Research Integrity Specialist @Highmark Health

Role Description

Ensures compliance with federal regulations (FDA and NIH) throughout the review and approval process of all research protocols involving human subjects.

Essential Responsibilities

• Plans and manages all activities pertaining to the IRB review and approval process of all research protocols involving human subjects submitted by researchers. (20%)
• Provides direction to researchers regarding protocol submission, correcting medical and technical deficiencies or protocols, informed consent documents, amendments, etc. (20%)
• Reviews independently protocols submitted by researchers for exempt or expedited review based on clinical expertise/training. (20%)
• Maintains the IRB database. (20%)
• Maintains compliance with all regulatory agencies, including institutional policy, procedures, guidelines, and federal regulations. (20%)

Qualifications

• Minimum: Bachelor's degree in Health Sciences or related field or relevant experience and/or education as determined by the company in lieu of bachelor's degree
• 3 years recent IRB or clinical research coordinator experience
• Preferred: CIM or CRC
• Certified IRB Professional (CIP)
• Certified IRB Manager

Requirements

• This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.
• Employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times.
• All employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures.
• Compliance with the company’s Code of Business Conduct, including adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.

Benefits

• Pay Range Minimum: $25.87
• Pay Range Maximum: $40.48
• Base pay is determined by a variety of factors including a candidate’s qualifications, experience, and expected contributions, as well as internal peer equity, market, and business considerations.
• The displayed salary range does not reflect any geographic differential Highmark may apply for certain locations based upon comparative markets.

Company Description

• Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities.
• Prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law.