Senior Coordinator, IRB Meeting

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.

This role is available remotely.

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
• ICFs
• 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

Job Requirements

Education

• Bachelor's degree or six (6) years of equivalent experience
• Certified IRB Professional (CIP) or attainment of CIP within one (1) year of eligibility

Experience

• 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

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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

Advarra employees must be fully vaccinated as a condition of employment unless a medical or religious exemption is approved as a reasonable accommodation. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen. New hires must be fully vaccinated or have received approval of an exemption as a reasonable accommodation as of their first day of employment.

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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)