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Advarra® is the premier provider of institutional review board (IRB) services for human subjects research 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.
We are looking for talent individuals to join our IRB Services team!
This position is based in either Seattle, WA, Blue Ash, OH, or Raleigh, NC or Columbia, MD.
General Summary: Manages the functioning of IRB meetings and assists the Manager, IRB Services and the Senior Manager, IRB Services to ensure adherence to all applicable federal regulations and timelines. Works with the Manager to identify strategies and methods to achieve organizational goals including providing training for new IRB Members and staff as appropriate.
Principal Duties & Responsibilities
Manages the functioning of IRB meetings:
Independently resolves complex issues for the IRB prior to the IRB meeting
Communicates opinions and questions of concern in an IRB meeting
Manages IRB assignment activities
Assigns reviewers to full board reviews in CIRBI
Facilitates and coordinates the administration of IRB meetings, in collaboration with the IRB Chair.
Manages webinar activities for IRB Meetings
Assists with assigning expedited reviews
Creates pre-review ICF's in compliance with US regulations, Health Canada, TCPS2, and ICH GCP when applicable
Tracks edits to the ICFs during IRB meetings
Prepares the meeting ICF for IRB meeting attendees and the post-meeting ICF for Client Services Coordinators
Attends at least one IRB meeting per week
Supports Ad Hoc IRB meetings
Coordinates audit requirements for IRB Services Management
Assists the Manager, IRB Services to ensure that the IRB adheres to all applicable Federal regulations and adheres to timelines:
Keeps informed on Federal Regulations and Guidelines in the area of Human Subject Protections
Independently solves problems and issues by applying Federal Regulations, FDA Info Sheets, IRB Written Procedures and other resources
Manages complex and challenging issues in the IRB meetings
Identifies issues for the IRB and the IRB chair to address through high-level understanding of protocols
Offers suggestions and ideas for process improvement to IRB Services Management.
Challenges opinions and questions of concern in an IRB meeting
Works with client services on any special issues that need to be reported to the IRB
Analyzes and suggests changes to IRB review methods
Works with the Manager, IRB Services to identify strategies and methods to achieve organizational goals:
Assists with the revision of IRB Written Procedures when required.
Serves as contact for Client Services teams for operational issues.
Assists with training of new IRB staff members
Assists with development of IRB Services work instructions, when required.
Conducts quality assurance and quality control on all work products to ensure highest level of quality
Attends conferences and workshops
Other duties as assigned
Bachelor's degree or six (6) years of equivalent experience
Certified IRB Professional (CIP) or attainment of CIP within one (1) year of eligibility
1 - 2 years' experience in IRB or clinical research setting that includes applying regulations to the protection of human subjects.
Intermediate computer skills, including proficiency with MS Office Suite and ability to effectively use proprietary system
Knowledge, Skills, Abilities
Knowledge of Federal laws and guidelines pertaining to Research and the Use of Human Subjects including the FDA and DHHS
Communicate clearly and professionally, both verbally and in writing; public speaking
High level of professionalism
Write and speak in English to compose business text such as letters, memos, e-mails and reports; copy or transcribe information; summarize or condense information; edit, revise, correct, proofread
Word process and type
Listen, understand and interpret scientific and medical dialogue to be able to quickly and accurately word process IRB meeting controverted issues.
Read and understand research texts such as medical protocols and Informed Consent Forms
Must have high level of attention to detail, accuracy and thoroughness; Problem solving skills
Highly organized and efficient; Process and procedure oriented
Excellent interpersonal skills to work professionally and effectively with others and provide high levels of customer service
Ability to follow written and verbal instructions and work independently as required plan, organize, schedule and complete work within deadlines
Ability to manage conflicting demands and priorities
Ability to adapt to changes in office technology, equipment and/or processes
Demonstrated consistency and dependability in attendance, quantity and quality of work
Physical and Mental Requirements
Sit or stand for extended periods of time at stationary work station
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 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.
Internal Number: SRCOO01064
About Advarra, Inc.
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.