Job Description:
• Manage study startup activities such as site selection, site qualification visits, and site activation.
• Prepare site initiation visit material and lead the training for protocol and case report forms for all sites.
• Lead the effort for User Acceptance Testing for the study database build.
• Lead the effort to draft the study-specific monitoring plan.
• Review study-related documents such as protocols, consent/assent forms, etc.
• Serve as the primary contact for questions related to protocol compliance throughout the study.
• Conduct regular monitoring visits to ensure studies are being executed in compliance with the protocol, and applicable regulations.
• Mentor other CRAs on the team.
• Manage project meetings related to monitoring activities.
• Lead study closeout and database lock activities.
• Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
Requirements:
• B.S. or B.A. and/or an equivalent combination of education or experience.
• CRA certification
• Minimum of 5 years of monitoring experience.
• Available to travel on short notice and independently manage travel schedules.
• Direct experience in participating in the execution of clinical research studies.
• Must have analytical skills, be detail-oriented and have good interpersonal skills.
• Knowledge of agency guidelines and requirements.
Benefits:
• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs
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