Clinical Research Associate/QA Lead

San Francisco Peninsula , CA | Direct Hire

Post Date: 10/27/2017 Job ID: 3011 Industry: Software/Hardware

POSITION: Senior Clinical Research Associate/ Quality Assurance Lead

REPORTS TO: Vice President of RA/QA/CA


The Senior Clinical Research Associate/Quality Assurance Lead is a dual role- managing the day-to-day operations of clinical study site management as well as overseeing daily QA activities in compliance with FDA QSRs and ISO 13485. .


Essential Responsibilities include the following (other duties may be assigned):


In capacity as Senior Clinical Research Associate: Perform clinical monitoring/site management activities in accordance with GCP, ICH and our company’s standard operating procedures

  • Manage clinical operation activities, including:

      • Arranging on-site visits and logistics

      • Establish site recruitment plan in collaboration with study site

      • Performing site qualification and site initiation procedures, including training of site research personnel

      • Proctoring clinical cases and ensuring compliance with study protocol

      • Monitoring completeness and quality of Regulatory Documentation

      • Data collection and analysis

      • Monitoring patient safety on-site and addressing any violations in a timely manner

  • Assist with clinical protocol preparation and submission to IRB

  • Generate study documents including case report forms, recruiting materials, and informed consent documents

  • Manage clinical database to include data entry, queries and reports.


In capacity as Senior Quality Assurance Lead: Interface with R&D and Operations teams on Quality support for new product development and ongoing manufacturing.

      • Participate on new product development team including risk management, test protocol development and quality plans.

      • Support inspection needs, review lot history documentation.

      • Assist with complaint investigation and reporting

      • Compile and report on quality metrics, including monthly dashboard and management review meetings.

      • Assist with continued development of company’s standard operating procedures





  • 3+ years related experience in the area of clinical research trial monitoring for medical device and/or

  • 3+ years related experience in quality assurance function/quality engineering for medical device industry

  • BS degree

  • Knowledge of federal and local regulations and policies pertinent to research involving human subjects

  • Knowledge of FDA QSRs and ISO 13485, MDD requirements

  • Excellent communication, interpersonal and organizational skills

  • Ability to collaborate in a team environment as well as work independently

  • Self-starter with the ability to manage multiple projects in a dynamic environment



  • Ability to sit, stand, and/or walk for no less than 8 hours a day.

  • Ability to lift a minimum of 25 pounds.

  • Ability to travel domestically and internationally (approximately 50%, but at times up to 80%).

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