About the role
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 all human subject’s research from survey research to first-in-human research sponsored by pharmaceutical companies, biotech companies, institutions, hospitals as well as clinics and private physician offices. Within the IRB, the regulatory department is responsible for the expedited review of research, the full board review of research and the drafting and writing of the meeting minutes. The regulatory department also collaborates with other parts of the organization on thought leadership, client guidance, and operational efficiencies.
Affiliated Board Members (ABM) are full-time Advarra employee board members who conduct IRB reviews on behalf of the organization. Based on educational background, experience, and expertise ABMs can be designated as either scientific or non-scientific and workload is distributed accordingly. A non-scientific ABM is a board member who does not have a scientific educational background or significant professional experience in a scientific field but has a strong understanding of research regulations and guidance.
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. Help ensure the timely execution of the core review activities of the Institutional Review Board, while preserving the highest quality of professionalism and regulatory compliance
Be a resource to answer questions and help to solve day-to-day challenges whether in collaboration with Advarra staff or other board members
Assist as necessary with the triaging and review of submissions for expedited or full board review
Attend full board meetings and present protocol related issues as needed
Identify to senior regulatory staff areas that would benefit from guidance, inconsistencies in Board reviews, and other like issues
Consult, as necessary, with sponsors, investigators, CROs on clinical and regulatory affairs
Work with Regulatory Leadership to identify membership needs and to help develop Board members to ensure consistency of Review Board related activities
Enhance and encourage a work atmosphere centered on accountability through motivation, team building, training, mentoring, collaboration, and respect to create a highly efficient and successful workplace
Location
This role is open to candidates working remotely in the United States.
Basic Qualifications
Bachelor’s Degree
One (1)+ years of IRB or Clinical Research Industry experience preferred, OR minimum 3 years’ experience in healthcare within the last 6 years
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 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.
Pay Transparency Statement
The base salary range for this role is $58,495 – $96,517. 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.
Originally posted on Himalayas