Job description

• Submits serious adverse events, Investigational New Drug (IND) reports, protocol addenda and/or other documents to Institutional Review Boards in accordance with prescribed procedures.
• Prepares Institutional Review Board continuing review reports in accordance with prescribed procedures.
• Maintains and updates IRB tracking database; perform quality assurance reviews of the tracking database; maintains up-to-date comprehensive regulatory and/or study binders; maintains protocols, consents and Institutional Review Board documents.
• Provides sponsors with updated regulatory documents; performs regular quality assurance reviews of local and remote working files.
• Assists in the interpretation and implementation of federal, state, and Excell Research policies and procedures as they apply to the clinical research activities.
• Plans, schedules, and coordinates research team meetings that are needed to facilitate communication about and coordination of research activities.
• Supports financial aspects related to grants and contracts, such as participant remuneration, distribution of bills and invoices, monitoring monthly budget expenses, and ensures that proper procedures related to financial aspects are followed.

Qualifications:

• Bachelor's degree preferred
• Must have keen attention to detail
• Experience with FDA regulatory requirements, include part 11 signature compliance, 1572, and FDF maintenance
• Familiarity with clinical research trials

Job Type: Part-time

Pay: From $25.00 per hour

Benefits:

• Retirement plan

Schedule:

• Self-determined schedule

Experience:

• Regulatory: 1 year (Preferred)

Work Location: Remote

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