Research Integrity Specialist

Highmark Health; Elm (PA); On-site; USD 36,000 - 56,000; Full time

Job summary

Allegheny Health Network is seeking an IRB Coordinator to ensure strict adherence to federal regulations (FDA/ NIH) in the review and approval of research protocols involving human subjects.

You will plan and manage IRB activities, guide researchers on submissions and amendments, review exempt or expedited protocols, and maintain the IRB database while upholding HIPAA and institutional privacy policies.

Compliance with all regulatory agencies and company policies is fundamental to this role.

Qualifications

• Bachelor's degree in Health Sciences or related field
• 3 years recent IRB or clinical research coordinator experience

Responsibilities

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

Skills

IRB experience

Regulatory compliance

Clinical research coordination

Education

Bachelor's degree in Health Sciences or related field

CIM

CRC

Certified IRB Professional (CIP)

Certified IRB Manager

Job description

Company : Allegheny Health Network

Job Description :

GENERAL OVERVIEW:

Ensures compliance with federal regulations (FDA and NIH) throughout the review and approval process 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

Disclaimer:

The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.

Compliance Requirement : This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies. As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, 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 as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.

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.

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

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