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

📋 Description

• Maintain a comprehensive 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 of the Institutional Review Board while upholding professionalism and regulatory adherence.

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

• Aid in the triaging and evaluation of submissions for expedited or full board reviews.

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

• Identify areas needing guidance, inconsistencies in Board reviews, and similar concerns to senior regulatory personnel.

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

• 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.

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

• Strong grasp of research regulations and guidelines.

• Master’s Degree preferred.

• Certified IRB Professional (CIP) certification preferred.

• Ability to learn and understand basic instructions.

• Capability to focus on and manage tasks and responsibilities effectively.

• Proficient in verbal communication, listening, understanding, responding, and speaking.

• Ability to sit or stand for prolonged periods at a stationary workstation.

• Ability to regularly carry, lift, and lower objects weighing up to 10 lbs.

• Candidates must be able to work remotely within the United States.