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

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