Clinical Research Associate/Senior Clinical Research Associate

Septerna
South San Francisco, CA
Category Research
Job Description
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. We are seeking a Clinical Research Associate/Senior Clinical Research Associate to lead various aspects of Sponsor oversight activities related to monitoring of our clinical trials.

Requirements

  • Bachelor’s degree or equivalent in life sciences or related field required
  • Additional coursework or certifications in clinical trial planning and operations desired
  • Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
  • Ability to work independently on multiple projects internally and with external vendors
  • Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions
  • Experience in Site Selection, Initiation, Interim and Close-Out visits
  • Experience in working across multiple regions and strong cross functional experience
  • Ability to coordinate or manage multiple projects to meet project timelines/milestones
  • Exercises independent judgment with problem-solving skills
  • Ability to understand and discuss relevant clinical data
  • Broad knowledge and understanding of the design and critical review of clinical studies
  • Previous CRA experience within biotech
  • Priority given to proven experience in CRO oversight and sponsor-level responsibilities
  • Good knowledge of ICH GCP and FDA regulations
  • Good verbal and strong written communication skills
  • Highly organized and detail oriented
  • Ability to multi-task and work in a flexible and dynamic organization
  • Willing to travel occasionally

Benefits

  • 401k Matching
  • Retirement Plan
  • Visa Sponsorship
  • Generous Paid Time Off
  • Annual target bonus for full-time positions
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