Clinical Trials Associate

Overview

The Clinical Trials Associate (CTA) supports clinical trials in the US by assisting the research teams to ensure the most effective and efficient conduct of clinical research by providing administrative and project tracking support. As a key contributor to the Clinical Affairs team, this position will also support various improvement projects. Hybrid (may consider remote for the right candidate).

• Provide support to clinical study Site Managers and Monitors while ensuring each clinical site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, enrollment, and action items resolution monitoring.
• Perform co-monitoring at investigative sites and interface with study personnel as needed
• Manage clinical trial Subject reminder systems to support site managers/monitors and share goal of high Subject retention
• Develop tracking mechanisms within for new clinical studies, maintain current systems for ongoing studies
• Manage the Clinical Affairs calendars, meetings, and other related activities including compilation and/or standardizing meeting minutes, action items, and follow up through resolution.
• Manage and maintain Trial Master Files (TMF) to allow for the following:
  • Ensuring regulatory documents remain updated and site remains compliant to protocol
  • Building systems and managing media disposition
  • Performing the ECO document approval process for Clinical files
  • Ensuring BIMO readiness
  • Conduct regular reviews of essential documents to ensure accuracy, compliance, proper filing
  • Represent the Clinical team during internal filing audits
• Assist with translation process of study documents
• Attend project team meetings and manage meeting minutes
• Manage clinical supplier audit schedules and files against applicable procedures
• Participate in developing and maintaining department systems initiatives, including related trainings
• Maintain current knowledge of applicable US and international clinical regulations
• Partner with Site Manager to manage and support site management activities
• Proactively recognize challenges and recommend corrective action
• Perform other duties as assigned
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

• BA/BS degree, a scientific major preferred; or equivalent work experience
• 2 plus years of demonstrated experience within the medical device industry
• Knowledge of regulatory requirements

• Proficient in Acrobat Adobe, Microsoft Word, Excel, and Project; and the ability to quickly become proficient in a variety of other software
• Excellent oral and written communication and critical thinking skills
• Understanding of medical terminology
• Ability to perform well-defined tasks with limited supervision
• Ability to exhibit good judgment, be creative, and achieve aggressive goals
• Ability to successfully work in a fast-paced environment
• Ability to be nimble and quickly adapt to change
• Ability to travel between 10-25%