Clinical Trials Associate
- Clinical Affairs
- Fremont, CA (Hybrid/Remote)
- 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
- 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%
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