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Supporting those affected by type 1 diabetes so they may lead full, healthy, beautiful lives, NOW.
Senior Clinical Research Specialist
Location
Massachusetts
Posted
5 days ago
Salary
$104.6K - $156.9K / year
Seniority
Senior
Job Description
Senior Clinical Research Specialist
Diabetes Youth Families
• 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. • Performs other duties as required.
Job 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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