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’s Institutional Biosafety Committee (IBC) conducts risk assessment for research involving recombinant or synthetic nucleic acid molecules and ensures adequate risk mitigation plans are in place in compliance with NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Affiliated IBC Committee members are full time staff at Advarra who conduct IBC reviews and conduct facility inspections on behalf of the organization. Affiliated IBC Committee members are staff members with scientific expertise either professionally or based upon education.
Job Duties & Responsibilities
- Maintain a superior level of knowledge regarding research involving recombinant or synthetic nucleic acid molecules and associated regulatory compliance.
- Perform facility inspections remotely or in person in accordance with NIH Guidelines and in support of Advarra IBC review.
- Help ensure the timely execution of IBC reviews, while preserving the highest quality.
- Be available to answer questions and help to solve day-to-day challenges whether in collaboration with Advarra staff or other IBC committee members
- Efficiently manage IBC submissions and outputs, ensuring quality and turn-around times are maintained
- Prepare, maintain and process accurate and complete client files and database tracking
- Proactively review client submissions, provide reviewer comments and shepherd the submission through the IBC review process to minimize the number of conditions of approval that may be required.
- Identify issues for escalation and collaborate with management and/or team members to resolve appropriately
- Facilitate written and oral communications with members and consultants for expert and consultation reviews
- Support IBC team members in ensuring meeting attendees are equipped with the information, tools and documents necessary to effectively participate in assigned meetings
- In capacity of IBC reviewer, identify appropriate and qualified materials for committee review to allow for an adequate in-depth review of the material under consideration
- Attendance at IBC committee meetings and presentation of protocol related issues
- Identify to senior IBC staff areas that would benefit from guidance, inconsistencies in IBC reviews and other like issues
- Assist IBC operations staff, as needed, with managing site lists, site registrations with the NIH and IBC member onboarding, or meeting outputs such as approval letters or meeting minutes.
- Participate, as necessary, in teleconferences with clients
- Consult, as necessary, with sponsors, CROs and research sites.
- 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
- Other duties as assigned
Location: This role is available remotely in the United States
Basic Qualifications
- Bachelor’s Degree required, preferably in a field related to science, healthcare or occupational or environmental health and safety
- Mastery of all processes associated within the functional area
- Demonstrate advanced to expert level proficiency in MS Office: Excel, Word, PowerPoint, Outlook
Preferred Qualifications
- MS or PhD
- 9+ years of IBC / biosafety experience
- Experience performing biosafety inspections in the clinical setting
- Prior familiarity with CIRBI or the Advarra IBC system
- Biosafety credentials (RBP/CBSP or SM(NRCM)), industrial hygiene (CIH) safety credentials (CSP)
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
Equal Employment Opportunity (EEO) Statement
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 $58,300 - $99,200. 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.
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)