Sr Clinical Research Associate (CRA)

Key Responsibilities

• Act as a customer advocate through a study life cycle.
• Understand and support study goals in alignment with corporate goals.
• Organize and maintain clinical study documentation (e.g., Trial Master Study Files).
• Prepare accurate and timely trip reports or site audit reports.
• Support the revision and implementation of Clinical Affairs SOPs/procedures.
• Support inspection readiness for the company, to ensure its contractors and vendors are prepared for FDA and other Health Authority GCP inspections.
• Support oversight of Trial Master Files.
• Provide support to Clinical Development and Operations for clinical planning, start-up, execution and close-out.

Requirements

• Bachelor’s degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology preferred.
• Minimum of five (5) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring, close-out visits) at an eye care Pharmaceutical, Biotech or CRO company.
• Pharmaceutical and ophthalmology experience required.
• Vendor oversight experience preferred.
• Thorough knowledge of ICH/GCP R3 Guidelines.

Skills

• Thorough knowledge of ICH/GCP R3 Guidelines.
• The ability to thrive with minimal supervision.
• The drive to resolve project-related problems and can prioritize workload for self and team.
• Mentoring of other CRAs on monitoring, internal procedures and query resolution.
• Excellent knowledge of MS Office, Excel, PowerPoint as well as data management and clinical trials software.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently.
• Collaboration and Team Building - Builds strong relationships and networks.
• Outcome Driven - Clearly defines mutual expectations of self and others in a team setting.

Benefits

Base pay range: $109,500 - $153,300 plus bonus, stock equity, and comprehensive benefits.

Benefits include health, dental and vision insurance benefits, generous paid time off, and more. For more details, please visit: Tarsus Pharmaceuticals, Inc. Benefits Snapshot.

Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer.