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

📋 Description

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

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

• Assist in the prompt execution of Institutional Review Board review activities while upholding professionalism and adhering to regulatory standards.

• Address inquiries and resolve daily challenges utilizing scientific knowledge and regulatory expertise.

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

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

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

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

• Collaborate with Regulatory Leadership to assess membership requirements 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 IRB or the Clinical Research Industry preferred, OR a minimum of 3 years’ experience in healthcare within the last 6 years.

• Strong comprehension of biological and/or pharmacological sciences through education or experience.

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

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

• Competence in learning and understanding basic instructions.

• Focus and attention to assigned tasks and responsibilities.

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