This is a fully remote position, open to applicants in United States.

📋 Description

• Maintain an exceptional understanding of regulatory requirements, Advarra’s Board Standard Operating Procedures, and Organizational Policies and Procedures.

• Ensure compliance of the Review Board with regulatory standards and organizational protocols.

• Assist in the timely execution of core review activities for the Institutional Review Board while upholding professionalism and adherence to regulations.

• Address inquiries and resolve daily challenges faced by Advarra staff and fellow board members.

• Support the triaging and evaluation of submissions for expedited or full board review.

• Participate in full board meetings and present protocol-related matters as necessary.

• Identify areas needing guidance, inconsistencies in Board evaluations, and related issues to escalate to senior regulatory personnel.

• Consult with sponsors, investigators, and CROs regarding clinical and regulatory matters.

• Collaborate with Regulatory Leadership to assess membership needs and develop Board members.

• Foster accountability through motivation, team building, training, mentoring, collaboration, and respect.

⛳️ Requirements

• Bachelor’s Degree.

• Preferred: One (1)+ years of experience in IRB or the Clinical Research Industry, OR a minimum of 3 years’ experience in healthcare within the last 6 years.

• Preferred: Master’s Degree.

• Preferred: Certified IRB Professional (CIP) certification.

• Familiarity with research regulations and guidance.

• Capability to sit or stand for extended durations at a stationary workstation.

• Ability to routinely lift, raise, and lower objects weighing up to 10 lbs.

• Capacity to learn and understand basic instructions.

• Strong focus and attention to tasks and responsibilities.

• Proficient verbal communication, along with listening, understanding, responding, and speaking skills.