Company :Allegheny Health NetworkJob 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 (RAPID). (20%)Maintains compliance with all regulatory agencies, including institutional policy, procedures, guidelines, and federal regulations. (20%)

QUALIFICATIONS:

Minimum

BA/BS in Health Sciences of related field3 years recent IRB or clinical research coordinator experience

Preferred

CIM or CRCCertified 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.

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 their race, color, religion, sex, national origin, sexual orientation/gender identity or any other category protected by applicable federal, state or local law. Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, sexual orientation/gender identity, protected veteran status or disability.

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 their race, color, age, religion, sex, national origin, sexual orientation/gender identity or any other category protected by applicable federal, state or local law. Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, age, religion, sex, national origin, sexual orientation/gender identity, protected veteran status or disability. 

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