Job Description
Who Are We?
Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs.
We are looking for exceptional team members who want an active role in building a rapidly growing biotech.
Position: Senior Clinical Research Associate
Location: South San Francisco, CA
Opportunity: 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.
Roles and 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.
Qualifications:
- Bachelor's degree in life sciences or related field preferred
- 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
Compensation: The salary range for this position is $115,000 to $121,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.
Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.
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.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Job Tags
Full time, Local area