Advisory / Regulatory, Medical Group, Private Industry
Principal 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
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 Executive Chair 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
Consult, as necessary, with sponsors, investigators, CROs on clinical and regulatory affairs
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 Executive Chair in annual evaluation of Board Members
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 work place
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
Advanced Degree in Medicine or comparable PhD
Previous Medical Experience required (MD or RN experience prefered)
3 years’ experience with an institutional IRB or with a healthcare or clinical research entity within the last 6 years preferred
5 years of work experience in a clinical setting
Advanced knowledge of regulations and guidance’s pertinent to human subject protection in the United States and Canada including but not limited to AAHRPP, FDA, OHRP and ICH
Knowledge, Skills, Abilities
Demonstrates comprehensive knowledge of business and team processes and how they relate to use and operation of company’s systems
Strong working knowledge of regulations related to protection of human research participants and related IRB requirements
Demonstrates leadership and decision-making skills
Demonstrates ability to communicate effectively orally and in writing – work harmoniously across all levels and offices of the organization
Ability to facilitate group discussion
Ability to analyze a variety of data to make fact-based decisions
Demonstrated consistency and dependability in performance, including quantity and quality of work
Ability to manage and prioritize multiple activities and projects, balancing accomplishment of daily operational activities with strategic projects
Demonstrated success in providing oversight and direction to others; setting and communicating goals and expectations, measuring accomplishments, holding others accountable, delegating responsibility, keeping others informed, coaching, mentoring, reinforcing positive behavior and managing conflict
High level of interpersonal skills to handle sensitive and confidential situations
Moderate computer skills including experience with MS Office products
Physical and Mental Requirements
Sit or stand for extended periods of time at stationary work station
The employee must occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
This position requires regular oral/written interaction with clients, team members and management
Infrequent traveling may be required within the United States
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.
Telecommuting is allowed.
Internal Number: Chair001
With a legacy stretching back to 1983, Advarra® is the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), and research quality and compliance consulting services in North America. Fully accredited by AAHRPP, Advarra serves the world’s leading pharmaceutical, biotechnology, medical device, and contract research organizations, as well as academic medical centers, health systems, investigative site networks, and therapeutic research consortia.To address the increasingly complex needs associated with research, Advarra leverages exceptional client service, innovative technology, and robust global regulatory expertise. Advarra also provides deep experience across all major therapeutic areas and continues to pioneer highly specialized review services for areas such as oncology and neurology.
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