Clinical Research Associate I (In-House)
Description

Position Description:


The Clinical Research Associate I (In-House) is responsible for supporting clinical operation teams and effectively coordinating in-house activities associated with study conduct in compliance with protocols and all applicable regulations to meet overall clinical and company objectives for timely execution of clinical studies in accordance with the highest ethical standards and scientific rigor. The Clinical Research Associate (In-House) position reports to Manager of Clinical Operations.

Requirements

Essential Functions

Include but are not limited to the following:

  • Support study start­up activities at sites by finalizing Informed Consent Form language, collecting essential study documents and delivering regulatory and patient binders, training tools and other necessary study supplies
  • Maintain clinical central files
  • Maintain the Electronic Trial Master File per clinical procedures and in compliance with GCP guidelines, FDA regulations and IRB requirements
  • Support IRB submissions, amendments and annual reports, as applicable
  • Maintain site contact information, coordinate site and patient payments, and create patient follow-up schedules for distribution
  • Assist with reconciliation of investigational products and supplies
  • Support audit readiness by maintaining proper clinical trial documentation, conducting routine internal clinical file assessments and participating in audits

Education, Experience and Skills Requirements:

  • Associates Degree in science/health-related degree (Health Science or RN preferred) or equivalent combination of experience and education
  • 0-1 year of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies
  • Working knowledge of CFRs, IDE, NDA, GCPs and ICH Guidelines 
  • Demonstrate strong interpersonal and organizational skills
  • Have excellent verbal and written communication skills along with a positive attitude 
  • Able to work in a fast-paced environment and complete tasks efficiently with appropriate direction, with a high attention to detail and accuracy

Other Requirements

  • Position may require occasional travel for employee’s education and team meetings outside of Valencia when virtual attendance is not available.

Location:

  • The position will be located at company headquarters in Valencia, CA. Remote position will be considered based on experience.