Coordinator II, IRB Support

Advarra•United States of America,

10h•$54,029 - $89,148•Remote

About The Position

This position provides administrative IRB Support services to the Boards in the independent preparation and management of high-quality board meeting minutes. This position will also offer general administrative support to the IRB Support Team. This position will also independently author reporting letters to government oversight agencies (FDA, OHRP) following IRB policies and procedures and standard operating procedures.

Requirements

Bachelor’s Degree or Associates Degree
3+ years industry or office experience

Nice To Haves

Achieved recognition from an accredited organization preferred (e.g., PRIM&R’s Certified IRB Professional (CIP) credentials or similar organization)
2+ years of IRB or Clinical Research Industry experience
Must be detail-oriented and possess problem solving skills
Ability to communicate effectively in English, both verbal and 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

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.
Assist Compliance Team with audit requests for meeting minutes.
Identify, communicate, and implement strategies for continuous improvement in IRB Support operational procedures.
Assist in IRB Support Department and Company projects as they relate to the IRB Support Team.
Provide administrative support within the team and other teams as needed.
Other duties as assigned.