Coordinator II, IRB Meeting

General Summary

• Supports the IRB Services team in the review of incoming submissions, meeting

  assignments and informed consent form (ICF) preparation.

Principal Duties & Responsibilities

• Support IRB meeting preparation and coordination:

  o Review submissions for full board assignment to ensure readiness for

  review

  o Assign submissions to upcoming IRB meetings, as directed

  o Send assignments and assignment updates to reviewers in CIRBI

  o Send clarifications between Client Services and Board reviewers in

  collaboration with Senior Meeting Coordinator

  o Assist with preparation of Meeting and Postmeeting ICFs, as directed

  o Assist with preparing meeting determinations in collaboration with Senior

  Meeting Coordinator

• Conduct an accurate pre-review of new and revised consent forms in regulatory

  compliance with applicable FDA, HHS, Health Canada,TCPS2 regulations, ICH

  GCP guidance, and operational compliance with Advarra Standard Operating

  Procedures and Work Instructions

  o Edit new and revised consent forms to ensure regulatory compliance and

  alignment with Advarra operational standards

  o Apply negotiated language to consent form documents as required by

  client agreements documented in mandatory language documents or

  MLD's.

  o Collaborate with Board members and staff to include all necessary edits to

  the consent form from the various stakeholders

  o Complete informed consent quality control check for self and others

• Maintain and increase individual regulatory knowledge to assist with

  organizational compliance

  o Maintain and increase knowledge of U.S. and/or Canadian Federal

  Regulations and Guidelines in the area of Human Subject Protections,

  drug research, device research, and cosmetic research

  o Complete standard Human Subjects Research Training, such as CITI, on

  a repeating cycle determined by management

  o Complete organizational training as required by management

  v.05/01/2022 IRB Meeting Coordinator II, US & Canada 2

  o Attend a minimum of four IRB meetings per month to enhance knowledge

  and understanding of IRB processes

• Offers process improvement suggestions to management
• Other duties as assigned

Education

• Bachelor's degree (preferred) or associate's degree

  Experience

• Minimum of 1 year of IRB or clinical research experience in addition to a

  bachelor's degree OR a minimum of 4 years of IRB or clinical research

  experience in addition to an associate's degree

• Proficient with MS Word and Outlook
• Familiar with Excel, PowerPoint, direct messaging applications such as Slack,

  remote meeting applications such as Zoom or RingCentral, and web-based

  proprietary software

Knowledge, Skills, Abilities

• Basic knowledge of Federal laws and guidelines pertaining to Human Subjects

  Research Protection

• Communicate clearly and professionally in English, both verbal and written
• Confident with public speaking
• High level of professionalism
• Able to edit technical and/or medical documents using current software/platforms
• Able to convert technical/medical information to lay terms
• Able to read and comprehend advanced technical/medical documents
• Able to compose business text such as letters, memos, and e-mails; edit, revise,

  correct, proofread

• Highly organized and efficient; Process and procedure oriented
• Able to provide focused and accurate work with a high attention to detail under

  time constraints

• Able to manage conflicting demands and priorities
• Able to work remotely and/or work with remote workers using the latest

  technology platforms

• Dependably produces high quality work

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

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 v.05/01/2022 IRB Meeting Coordinator II, US & Canada 3 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

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)