Research Compliance Specialist Senior

Company :

Job Description : 

GENERAL OVERVIEW:

Ensures compliance with federal regulations, state laws and institutional guidelines throughout the review and approval process of all research involving human subjects.

ESSENTIAL RESPONSIBILITIES:

• Manages work flow processes and conducts activities pertaining to IRB review and approval for protocols involving human subjects submitted by researchers; monitors the protocol review process to ensure complete and expedient review of all protocols and ensures all special regulatory issues have been properly addressed and approvals/authorizations obtained. (20%)
• Provides direction and advice to researchers involving human subject research protocols regarding submission, completeness/accuracy, informed consent documentation, amendments, continuing review protocols and adverse events submission; reviews submitted protocols for exempt or expedited review and approval. (20%)
• Guides and advises IRB staff, investigators, research teams, hospital administrators and staff regarding regulations and compliance activities as they pertain to clinical research of human subjects; administers Adverse Event Committee and IRB Committee meetings, including minute taking. (20%)
• Assists with compliance to all federal regulations, institutional policies and procedures, guidelines and state law in IRB files and protocols; assists in the development of policies and procedures. (20%)
• Assists with the educational sessions with researchers and study coordinators, oversees the management of the IRB database and completes other duties as assigned. (20%)
• Other duties as assigned.

QUALIFICATIONS:

Minimum

• Bachelor’s degree in health-related field or relevant experience and/or education as determined by the company in lieu of bachelor's degree
• 5 years IRB or clinical research experience
• Working knowledge and understanding of scientific and medical concepts
• Advanced understanding and application of theoretical knowledge of research compliance as it relates to human subject research and IRB functions

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, 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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