Senior Clinical Research Associate

Epicrispr BiotechnologiesSouth San Francisco, CA
Onsite

About The Position

Epicrispr Bio is seeking a detail-oriented and proactive Senior Clinical Research Associate (CRA) to support the execution and oversight of clinical trials. This role will play a key part in ensuring studies are conducted in compliance with regulatory requirements, GCP guidelines, and company protocols, while maintaining the highest standards of quality and data integrity. The ideal candidate will bring a strong foundation in clinical operations, experience working cross-functionally with CROs and clinical teams, and the ability to independently manage site activities while contributing to process improvements in a fast-paced, growing environment. This is an opportunity to have meaningful impact on clinical development programs while helping to build and scale operational excellence within the organization.

Requirements

  • 2 - 5+ years of CRA or clinical research experience (biotech, pharma, or CRO environment)
  • Strong understanding of GCP, ICH guidelines, and clinical trial processes
  • Experience working with CROs and managing clinical sites
  • Excellent organizational, communication, and problem-solving skills
  • Ability to manage multiple priorities in a fast-paced environment

Nice To Haves

  • Bachelor’s degree in life sciences or related field preferred

Responsibilities

  • Assist the Clinical Operations team with on-site sample operations, including sample receipt, registration, and shipments in a GCP environment.
  • Support clinical trial manager with site management, including: site startup activities, co-monitoring visits alongside CRO, reviewing monitoring visit reports, coordinating vendor trainings, reviewing study newsletters, and other duties as needed, in alignment with study priorities and CTM guidance.
  • Assist clinical trial manager with data verification and ICF reviews as needed, alongside CRO, to support data quality and protocol compliance.
  • Partner with CTM and clinical team to help identify areas to improve our processes, with priorities defined by the CTM, and support implementation of agreed-upon improvements.
  • Identify and communicate site-level issues, protocol deviations, and operational risks to the CTM to support timely resolution.
  • Maintain study trackers, logs, and documentation across regulatory, site, data, and sample operations to support study oversight and execution.

Benefits

  • Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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