Affiliated Board Member (Scientific)

Job Overview Summary

Advarra has as its core function the institutional review board (IRB) review of all human subject's research from survey research to first-in-human research sponsored by pharmaceutical companies, biotech companies, institutions, hospitals as well as clinics and private physician offices. Within the IRB the regulatory department is responsible for the expedited review of research, the full board review of research and the drafting and writing of the meeting minutes. The regulatory department also collaborates with other parts of the organization on thought leadership, client guidance, and operational efficiencies. Affiliated Board Members (ABM) are full-time Advarra employee board members who conduct IRB reviews on behalf of the organization. Based on educational background, experience, and expertise ABMs can be designated as either scientific or non-scientific and workload is distributed accordingly. A scientific ABM is a board member who has scientific expertise either professionally or based upon education.

Job Duties & Responsibilities

• Maintain superior level knowledge of, and ensure Review Board compliance with, regulatory requirements, Advarra's Board Standard Operating Procedures and Organizational Policies and Procedures.
• Help ensure the timely execution of the core review activities of the Institutional Review Board while preserving the highest quality of professionalism and regulatory compliance.
• Be a resource to answer questions and help to solve day-to-day challenges whether in collaboration with Advarra staff or other board members, utilizing scientific knowledge and regulatory expertise.
• Assist as necessary with the triaging and review of submissions for expedited or full board review.
• Attend full board meetings and present protocol related issues as needed.
• Identify to senior regulatory staff areas that would benefit from guidance, inconsistencies in Board reviews, and other like issues.
• Consult, as necessary, with sponsors, investigators, CROs on clinical and regulatory affairs.
• Work with Regulatory Leadership to identify membership needs and to help develop Board members to ensure consistency of Review Board related activities.
• Enhance and encourage a work atmosphere centered on accountability through motivation, team building, training, mentoring, collaboration, and respect to create a highly efficient and successful workplace.

Location

This role is open to candidates working remotely in the United States.

Basic Qualifications

• Bachelor's Degree
• One (1)+ years of IRB or Clinical Research Industry experience preferred, OR minimum 3 years' experience in healthcare within the last 6 years

Preferred Qualifications

• Master's Degree or other graduate level degree with an emphasis in a scientific background
• A strong understanding of biological and/or pharmacological sciences (either through education or experience)