Clinical Research Associate – CRA II/Senior, Metabolic

Job Description:

• Manage clinical sites from identification through closeout
• Serve as the primary point of contact for assigned clinical sites
• Conduct qualification, site initiation, monitoring, and termination visits at assigned clinical sites
• Prepare timely visit and contact reports
• Manage site quality and delivery
• Address site questions and resolve issues
• Oversee study integrity and build relationships with investigators and site staff
• Review trial performance and safeguard study participants' rights, safety, and well-being
• Develop patient recruitment strategies to support enrollment timelines
• Ensure compliance with SOPs, study protocols and amendments, Good Clinical Practice, and regulatory requirements
• Evaluate reported data quality and integrity, site performance, and investigational product accountability
• Monitor regulatory documentation completeness and quality
• Perform site document verification

Requirements:

• At least 18 months of direct onsite monitoring experience as a Clinical Research Associate
• Metabolic/MASH and/or Obesity clinical trial monitoring experience
• Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline
• Knowledge of Good Clinical Practice, applicable regulatory requirements, and clinical trial processes
• Experience using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word
• Strong site relationship management, problem-solving, communication, interpersonal, written, verbal, organizational, and attention-to-detail skills
• Ability to work independently with urgency and limited oversight
• Ability to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines
• Ability to collaborate within a matrixed team and communicate clearly with internal and external stakeholders
• Ethical, patient-focused approach
• Ability to work in the United States

Benefits:

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance
• Paid time off
• Life insurance
• Potential eligibility for additional incentives, bonuses, or other compensation programs