Sr Clinical Research Associate in San Diego, CA at Volt

Date Posted: 5/12/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    San Diego, CA
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
    5/12/2020
  • Job ID:
    229407
  • Contact Name
    Volt Branch
  • Phone
    714-921-7460

Job Description

Volt Workforce Solution has an excellent opportunity for Sr. Clinical Research Associate for an estimated one-year contract. Our client is a cutting edge clinical-stage biotechnology company located in San Diego. You must reside in Southern California to be considered. 

Responsibilities:

  • Contributes to monitoring plans using a risk-based approach (e.g. Risk Based Monitoring). Provides monitoring and study support resources to all studies.
  • Develops framework for consistency in monitoring oversight across clinical programs.
  • Reviews study protocol and study plans from an operational/monitoring perspective and provides meaningful and logical insights into its feasibility and appropriateness.
  • Uses study monitoring metrics to monitor recruitment, site visits, data quality, patient safety, timely submission of trip visit reports, timely escalation of any monitoring quality issues, etc.
  • Contributes to development of patient recruitment strategies and identifies barriers to recruitment and proposes solutions.
  • Fosters relationships with CRO study management and monitoring counterparts during all stages of study (start up, conduct, closeout, and query resolution/data cleanup).
  • Oversees monitoring and study support team for quality and compliance.  Identifies issues and escalates any areas of concern, including study conduct or personnel issues. Works with the CRO Clinical Lead/Lead CRA in managing communications and training for CRO CRAs.
  • Leads, trains and helps develop contracted CRAs.
  • Ensures consistency in processes across all programs and strict adherence to SOPs, regulations and guidelines.
  • Serve as the face of the company at monitoring oversight visits.  Cultivate site relationships through discussions with PI and site staff.  Address all study related questions.
  • Perform and oversee SSVs / SIVs / SMVs across programs as needed.
  • Manage vendor activities for clinical studies ensuring that vendors are adhering to timelines, budget and are delivering quality.

Education and Licenses

  • Bachelor’s degree in Science, Healthcare, or a related field.

Volt is an equal opportunity employer