Coordinator I, IRB Support

Job Duties & Responsibilities

• Attend IRB Meetings as assigned and draft meeting minutes:
• Attend at least two IRB meeting per week, more when business needs require, and prepare draft minutes of IRB meetings using tools such as Zoom, WebEx, and SharePoint
• Prepare for IRB meetings by conducting a pre-review of the assigned agenda to ensure all regulatory requirements are accurately identified for each submission by utilizing internal support documents, such as the pre-review checklist and minutes notes document
• Collaborate with the Meeting Coordinator and the Board Chair prior to the IRB meeting to review assigned agenda items to identify any questions or concerns with the regulatory requirements, as needed
• Record meeting minutes in a timely manner, generally sending for IRB Support QC review within 4 business days of the IRB meeting, focusing on documentation of controverted issues identified during the IRB meeting, compliance with IRB policies and procedures, standard operating procedures and Meeting Minutes template and work instructions,
• Proofread and edit final IRB meeting minutes to ensure accuracy
• Collaborate with the Board Chair to edit and finalize IRB meeting minutes in a timely manner
• Provide IRB meeting attendance coverage for other IRB Support Coordinators as needed
• Maintain meeting minutes compliance with U.S. and/or Canadian Regulations and Guidelines in the area of Human Subjects Protections
• Complete standard Human Subjects Research Protections Training, such as CITI, on a repeated cycle as determined by management
• Complete organizational training as determined by management
• Assist in IRB Support Department and Company projects as they relate to the IRB Support Team
• Offer process improvement initiatives to management, as applicable
• Other duties as assigned

Location

• This role is open to candidates working remotely in the United States.

Basic Qualifications

• Bachelor’s Degree or Associates Degree
• 2+ years industry or office experience

Preferred Qualifications

• 1 year of IRB or Clinical Research Industry experience
• Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Protections Research
• Must be detail-oriented and possess problem solving skills
• Ability to communicate effectively in English, both verbal and in written
• Effective written communication skills, including ability to summarize complex discussions
• Excellent interpersonal skills to work effectively with others and provide high levels of customer service
• Ability to follow 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
• Flexibility with changing priorities
• Intermediate computer skills required, including experience with Microsoft Office products

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
• Advarra is an equal opportunity employer that is committed to providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability, genetic information, or any other status or characteristic protected by federal, state, or local law.

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