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 regulatory requirements, Advarra’s board standard operating procedures, and organizational policies
- Act as a point of contact for Advarra operations staff, assisting with day-to-day challenges
- Chair one or more weekly meetings
- Complete expedited reviews for minimal risk research, continuing reviews, investigational brochure updates, and prompt reporting events
- Respond to protocol and informed consent questions for minimal risk or full board protocols
- Ensure appropriate triaging of submissions for minimal risk or full board review
- Review amendments for scientific and non-scientific requirements
- Oversee pre-review of protocols
- Identify areas for guidance and inconsistencies in Board reviews
- Participate in clinically and regulatory-oriented teleconferences
- Consult with sponsors, investigators, and CROs on clinical and regulatory affairs
- Attain and maintain necessary regulatory knowledge for medical device reviews
- Work with Executive Chair to identify membership needs and develop board members
- Assist in the annual evaluation of board members
- Onboard and train new unaffiliated board members
- Perform co-chair duties during chairperson onboarding
- Foster a work atmosphere focused on accountability, motivation, team building, training, mentoring, collaboration, and respect
- Identify qualified resources for the board to ensure adequate review expertise
Location
This role is open to candidates working in one of the following locations: 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
Preferred Qualifications
- Master’s degree
- Certified IRB Professional (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 $86,900 - $147,900. 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
