IRB Operations Specialist (Remote)

About the role

Supports data collection, document management and analysis, client reporting, and problem resolution.

Responsibilities

• Prepare documents for review in accordance with company policies and regulatory requirements
• Provide accurate document identification and data entry
• Finalize and deliver documents to clients
• Meet assigned metrics around speed and accuracy
• Deal effectively with high work volume, rigid deadlines, and frequent changes

Requirements

• Maintain close attention to detail
• Able to proofread and detect errors in typing, spelling, grammar, syntax, and punctuation
• Read and interpret documents such as protocols for clinical investigations, medical, literature, safety rules, operating and maintenance instructions
• Maintain confidentiality
• Must have strong analytical skills with a high degree of accuracy in work
• Advanced knowledge of Microsoft Word, Excel, Outlook, Databases and Adobe
• Knowledge of FDA regulations as they relate to research (preferred)
• Must be able to maintain confidentiality
• Experience working with medical terminology (preferred)
• Able to work independently, utilize discretionary judgment, and be a pro-active team player
• Exhibit excellence in: Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Customer service- understanding the importance of meeting client requests and adapting to changing needs. Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team

Qualifications

• Bachelor's or Associate's Degree preferred, or a combination of equivalent education and experience
• Two+ years of experience working in an office setting where proofing documents and attention to detail are essential elements of your job requirements
• Strong analytical skills with a high degree of accuracy in work
• Advanced knowledge of Microsoft Word, Excel, Outlook, Databases and Adobe
• Knowledge of FDA regulations as they relate to research (preferred)
• Must be able to maintain confidentiality
• Experience working with medical terminology (preferred)
• Able to work independently, utilize discretionary judgment, and be a pro-active team player
• Exhibit excellence in: Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Customer service- understanding the importance of meeting client requests and adapting to changing needs. Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team