Manager, Regulatory Compliance

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

Job Overview Summary

The Regulatory Compliance Manager is responsible for implementing the Global Review Support and Compliance program to ensure compliance with the company’s Global Review Services Regulatory department with recognized regulations, client requirements, best practices, and guidelines.

The Regulatory Compliance Manager reports to the Executive Director, and works directly with the Director, Regulatory Compliance to help design, implement, and maintain the Global Review Support and Compliance program, and may lead in the development of policies, procedures, and corrective preventative action plans (CAPA) in support of internal regulatory compliance audits. Leadership, customer support and education, critical thinking, adaptability, leading change, and developing self and others are important for success in this role.

Job Duties & Responsibilities

• Implement the compliance program across Global Review Services which includes Advarra’s IRB (Institutional Review Board) and IBC (Institutional Biosafety Committee).
• In consort with the Director, develop and implement quality systems and procedures to ensure compliance with regulations, best practices, and guidelines that ensures reliability and consistency with respect to IRB and IBC review and regulatory activities.
• May lead internal regulatory compliance audits to ensure all IRB and IBC determinations and documentation are accurate.
• Implement the CAPA program, resolution of audit findings, quality improvement projects and as needed collaborate with Advarra’s Corporate QA department.
• Assist with the accreditation and certification requirements that pertain to Global Review Services.
• Foster collaborative, educational working relationships with constituencies.
• Other duties as assigned.

Location

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

Basic Qualifications

• Bachelor’s Degree in relevant science or engineering (including life sciences, medical technology, engineering or equivalent)
• Seven or more years of IRB / IBC or related Human Research Protection Program experience. Ideally, two or more years with an IRB / IBC focus on quality assurance / quality improvement activities (e.g. CAPA, audits, documentation, education, project management)
• Leadership experience with evidence of developing people and leading improvement activities.
• Excellent communication and organizational skills, and attention to detail
• Advanced computer skills, including the use of MS Office products, IRB or IBC Management system(s), and CRM software

Preferred Qualifications

CIP® Certification

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

Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.

Pay Transparency Statement

The base salary range for this role is $97,100 - $165,200. 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.