Irb Chairperson Jobs

Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Connecting the clinical research ecosystem, Advarra delivers solutions through a site-centric approach that unifies and accelerates the drug development lifecycle, making clinical trials safer, smarter, and faster.
General 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.
This position is available remotely.
Principal Duties & Responsibilities

• Ensure the appropriate triaging of submissions for minimal risk or full board review
• Participate, as necessary, in clinically-oriented and regulatory-oriented teleconferences with clients
• Consult, as necessary, with sponsors, investigators, CROs on clinical and regulatory affairs
• 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
• Other duties as assigned
• Oversee pre-review of protocol
• Act as a point of contact for Advarra operations staff, answering questions and helping to solve day-to-day challenges
• Review amendments as appropriate in terms of the need for scientific and non-scientific requirements
• Identify to the Senior Chair Director (s) and IO areas that would benefit from guidance, inconsistencies in Board reviews, and other like issues
• Participate in the onboarding and training of new unaffiliated board members, including description of different submission types, review submission process, and meeting interactions.
• 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
• 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
• Maintain superior level knowledge of, and ensure review board compliance with regulatory requirements, Advarra’s board standard operating procedures and organizational policies and procedures
• Work with the Executive Chair 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
• Perform co-chair duties when a new chairperson is onboarding, providing support for assigned meetings.
• Chair one or more meetings a week
• Attain/maintain necessary regulatory knowledge and skills to perform medical device reviews.
• Respond to protocol related and informed consent questions relating to minimal risk or full board protocols based upon a solid knowledge of regulatory requirements

Education

• Certified IRB Professional (CIP) certification preferred
• Bachelor’s Degree required; Master’s degree preferred

Experience

• 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.
• 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.

Knowledge, Skills, Abilities

• Ability to work independently and in collaboration with internal and external clients to develop solutions to complex problems.
• Maintains confidentiality in the review of any Board and study-related material(s).
• Knowledge of Advarra’s Board Standard Operating Procedures and Organizational Policies and Procedures.
• Excellent relationship-building skills.
• Advanced oral and written communication skills.
• Attention to detail with a high level of accuracy.
• Ability to multi-task, managing conflicting demands and priorities.
• Ability to research and analyze laws, regulations and guidance, and to provide recommendations.
• Comprehensive knowledge and understanding of U.S., Canada, FDA and OHRP regulations and ICH Guidance for institutional review boards.
• Demonstrated leadership skills.
• Ability to facilitate group discussion.
• Adherences to the highest ethical standards.
• In-depth knowledge of federal regulations, ethical principles and research involving human subjects, including but not limited to pharmaceutical and device trials.
• Demonstrated consistency and dependability in quality and quantity of work.
• Ability to plan, organize, schedule and compete work within deadlines.

Physical And Mental Requirements

• This position requires regular oral/written interaction with clients, team members and management
• Sit or stand for extended periods of time at stationary workstation.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
• Infrequent traveling may be required within the United States

EEO Statement
Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets