Clinical Research Associate (CA)

Category: CRA
Job #: 10622
Location: Aliso Viejo, CA (surrounding area)
Job Type: Perm
Rate / Salary Range: Competitive Salary

One of our sponsor clients is looking for a perm CRA to join their fast paced, dynamic team.  They are looking for someone with at least 2 years' experience monitoring. There is a lot of room to grow and minimal travel (25% on average). This client is considering CRA II and Sr CRA level candidates.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
  • Develop and implement site recruitment, selection and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
    Manage one or multiple studies.
  • Monitor product supplies/accountability including proper storage, dispensation, and disposal.
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:
  • You will need to go into the office in Aliso Viejo CA for 3 days a week and will have one site in CA
  • Must be well-versed in documentation and regulatory
  • Having experience monitoring Device studies is preferred
  • Bachelor's Degree Required
  • A Nursing or Medical Background or a Master's Degree in a Life Science is a plus
  • Being technologically savvy is a plus - currently on a TMF but will be on eTMF in the future so knowing the nomenclature for TMFs would be good

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