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Advancing clinical research: safer, smarter, faster
Coordinator II, IRB Support
Location
United States
Posted
25 days ago
Salary
$54.0K - $89.1K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Coordinator II, IRB Support
Advarra
Role Description 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 and independently author reporting letters to government oversight agencies (FDA, OHRP) following IRB policies and procedures and standard operating procedures. Job Duties & Responsibilities - Attend IRB Meetings as assigned and draft meeting minutes: - Attend at least two IRB meetings 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. Qualifications - Bachelor’s Degree or Associates Degree. - 3+ years industry or office experience. Requirements - 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. Physical and Mental Requirements - Sit or stand for extended periods of time at a 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. Benefits - The base salary range for this role is $54,029 - $89,148. - This position may also be eligible for a variable bonus in addition to base salary. - Health coverage, paid holidays, and other benefits may be included.
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