Coordinator I, IRB Support, Minutes jobs in United States
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Advarra · 11 hours ago

Coordinator I, IRB Support, Minutes

Advarra is a leader in clinical research committed to advancing human health through ethical review services and innovative technology solutions. The Coordinator I, IRB Support role involves providing administrative support to the IRB Boards by preparing high-quality meeting minutes and collaborating with team members to ensure compliance with regulatory requirements.

Pharmaceutical

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

Qualification

IRB experienceHuman Subjects ProtectionsMicrosoft OfficeEffective communicationDetail-orientedProblem solvingInterpersonal skillsOrganizational skillsAdaptability

Required

Bachelor's Degree or Associates Degree
2+ years industry or office experience
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

Preferred

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

Benefits

Variable bonus
Health coverage
Paid holidays
Other benefits

Company

Advarra

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Advarra leverages exceptional client service, innovative technology, enhanced regulatory expertise and global research compliance services.

Funding

Current Stage
Late Stage
Total Funding
unknown
2022-06-10Acquired

Leadership Team

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Gadi Saarony
Chief Executive Officer
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Brian Hart
Chief Technology Officer
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Company data provided by crunchbase