Moximed · 18 hours ago
Clinical Trials Associate
Fremont, CA
Full-time
Hybrid
Entry Level
2+ years expMoximed is focused on advancing clinical trials in the medical device industry, and they are seeking a Clinical Trials Associate to support research teams in the effective conduct of clinical studies. The role involves providing administrative support, managing trial documentation, and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareMedical Device
Responsibilities
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!
Qualification
Required
BA/BS degree, or equivalent work experience
Proficient in Acrobat Adobe, Microsoft Word, Excel, and Project
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
Preferred
a scientific major preferred
2 plus years of demonstrated experience within the medical device industry
Knowledge of regulatory requirements
Ability to travel between 10-25%
Company
Moximed
Moximed develops innovative therapies for patients with knee osteoarthritis.
11-50 employees
Funding
Current Stage
Late StageTotal Funding
$244.22MKey Investors
Elevage Medical TechnologiesAdvent Life SciencesRunway Growth Capital
2024-08-13Series D· $61M
2022-08-16Series C· $40M
2022-08-16Debt Financing
Leadership Team
Anton Clifford
Founder and CTO
Michael Mydra
SVP, Reimbursement & Market Access
Recent News
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