Chairperson II

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

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, and ensure review board compliance with regulatory requirements, Advarra’s board standard operating procedures and organizational policies and procedures


• Act as a point of contact for Advarra operations staff, answering questions and helping to solve day-to-day challenges


• Chair one or more meetings a week


• Complete expedited reviews based on status as a scientific or nonscientific expertise, including, but not limited to, minimal risk research, continuing reviews, investigational brochure updates, and prompt reporting events


• Respond to protocol related and informed consent questions relating to minimal risk or full board protocols based upon a solid knowledge of regulatory requirements


• Ensure the appropriate triaging of submissions for minimal risk or full board review


• Review amendments as appropriate in terms of the need for scientific and non-scientific requirements


• Oversee pre-review of protocol


• Identify to the Senior Chair Director(s) and IO areas that would benefit from guidance, inconsistencies in Board reviews and other like issues


• Participate, as necessary, in clinically-oriented and regulatory-oriented teleconferences with clients


• Contributes as a subject-matter expert or demonstrates leadership in specific regulatory or operational processes


• Collaborate with other Advarra units/departments, representing the chairpersons.


• Consult, as necessary, with sponsors, investigators, CROs on clinical and regulatory affairs


• Attain/maintain necessary regulatory knowledge and skills to perform medical device reviews.


• Work with the Senior Chair Director(s) to identify membership needs and to help develop board members to ensure consistency of review board related activities; assist the Senior Chair Director(s) in annual evaluation of board members


• Participate in the onboarding and training of new unaffiliated board members, including description of different submission types, review submission process, and meeting interactions.


• Contribute to the onboarding and training of new affiliated board members, describing, among other things, the full board review process, interaction between expedited reviewers and full board reviewers, and key submission issues.


• Lead or contribute to the onboarding of new chairpersons and serve as a key mentor during the chairperson training process.


• Enhance and encourage a work atmosphere centered on accountability through motivation, team building, training, mentoring, collaboration, and respect in an effort to create a highly efficient and successful workplace


• Identify appropriate and qualified resources for the board, ensuring appropriate expertise involved to allow for an adequate in-depth review of the material under consideration

Location

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

Basic Qualifications

• Bachelor’s degree required


• 1 year of service chairing IRB meetings or similar experience; minimum of 3 years’ 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)

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.

The base salary range for this role is $137,180 - $265,373. 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.