Senior Clinical Medical Writer
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 Apply tot his job