Job Overview Summary
Advarra has as its core function the institutional review board (IRB) review of a broad spectrum of research ranging from survey research to first-in-human research and sponsored by pharmaceutical companies, biotech companies, institutions, hospitals as well as clinics and private physician offices. The regulatory group is responsible for the expedited review of research, the full board review of research and the documentation of the meeting minutes. The regulatory group also collaborates with other parts of the organization on thought leadership, client guidance and operational efficiencies.
At Advarra, the Chairperson leads discussion at full board meetings and ensures that reviews are completed in accordance with Advarra policy and appropriate regulations. This position works with the Chair Director, Senior Chair Director(s), and the Institutional Official (IO) to ensure that Advarra effectively fulfills its obligation to help protect human research subjects.
Job Duties & Responsibilities
• Maintain superior level knowledge of regulatory requirements, Advarra's board standard operating procedures, and organizational policies.
• Act as a point of contact for Advarra operations staff, assisting with day-to-day challenges
• Chair one or more weekly meetings.
• Complete expedited reviews for minimal risk research, continuing reviews, investigational brochure updates, and prompt reporting events.
• Respond to protocol and informed consent questions for minimal risk or full board protocols.
• Ensure appropriate triaging of submissions for minimal risk or full board review.
• Review amendments for scientific and non-scientific requirements.
• Oversee pre-review of protocols.
• Identify areas for guidance and inconsistencies in Board reviews.
• Participate in clinically and regulatory-oriented teleconferences.
• Consult with sponsors, investigators, and CROs on clinical and regulatory affairs.
• Attain and maintain necessary regulatory knowledge for medical device reviews.
• Work with Chair Director(s) to identify membership needs and develop board members.
• Assist in the annual evaluation of board members.
• Onboard and train new unaffiliated board members.
• Perform co-chair duties during chairperson onboarding.
• Foster a work atmosphere focused on accountability, motivation, team building, training, mentoring, collaboration, and respect.
• Identify qualified resources for the board to ensure adequate review expertise.
Location
This role is open to candidates working remotely in Canada.
Basic Qualifications
• Bachelor's degree in a related field.
• 1+ years of service chairing IRB meetings or similar experience; 3+ years of experience with an institutional IRB or research experience with a healthcare or clinical research entity within the last 6 years.
• Advanced knowledge of all regulations and guidance pertinent to human subject protection in the United States and Canada including, but not limited to AAHRPP, FDA, OHRP, and ICH.
• Moderate computer skills including experience with MS Office products.
• Certified IRB Professional (CIP) certification within 2 years of employment.
Preferred Qualifications
• Graduate degree (MS, MA, MD, PhD, DO, etc)
• Advanced knowledge of all regulations and guidance pertinent to human subject protection in the United States and Canada including, but not limited to AAHRPP, FDA, OHRP, and ICH.
• Moderate computer skills including experience with MS Office products.
• Certified IRB Professional (CIP) certification within 2 years of employment.
Physical and Mental Requirements
• Sit or stand for extended periods of time at stationary workstation.
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Learn and comprehend basic instructions.
• Focus and attention to tasks and responsibilities.
• Verbal communication; listening and understanding, responding, and speaking.
Pay Transparency Statement
The base salary range for this role is $125,000 - $160,000 CAD. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.