Clinical Research Associate

Responsibilities:

  • Conduct qualification, initiation, monitoring and closeout visits at clinical sites located in different countries and geographies, such as and not limited to EU, USA, Canada, Japan, South Korea, China, Taiwan and others.
  • Create and maintain documentation through accurate and detailed visit preparation and outcome summary reports.
  • Review all source records for patient safety and ensure complete documentation of all subject safety events.
  • Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
  • Monitor source documents and compare/verify the data to EDC/(Other CRF, where applicable) for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria.
  • Follow through after visit to outstanding requests/needs are fulfilled.
  • Ensure compliance with protocol and overall clinical objectives.
  • Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
  • Assist in organizing documentation for regulatory submission, including IDE and PMA FDA submission
  • Work closely with other CRAs for coverage in collecting and reviewing regulatory documentation and assuring consistency between RMF and site files
  • Responsible for accurate and timely oversight and maintenance of RMF

 

Required Skills and Experience:

These are only minimum qualifications for this position at this grade level.  Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level and company need:

  • Bachelor’s degree in a life science field and basic familiarity with medical terminology
  • At least 2-3 years relevant industry experience in clinical research environment
  • Basic computer skills with proficiency in Microsoft Word and Excel required, PowerPoint and Database experience desirable
  • Ability to foster relationships with clinical sites and colleagues
  • Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
  • Able to work independently with excellent time management skills
  • Approximately 50% travel that will vary over time, including limited international travel to Asia/US/Canada/Europe (able to travel abroad and enter countries of sites locations, i.e. obtain entry permits, visas).
  • Comply with local and international regulations associated with personal health amd other medical requirements in order to be able to conduct working visits associated with this position to clinical sites and countries of their location.

 

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