Septerna · 8 hours ago
Clinical Research Associate/Senior Clinical Research Associate
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$135K/yr - $160K/yrSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients. The CRA/Senior CRA plays a crucial part by leading various aspects of Sponsor oversight activities related to monitoring clinical trials and ensuring compliance with study and regulatory standards.
BiotechnologyInformation TechnologyMedicalSoftware
Responsibilities
Lead and conduct sponsor oversight visits to ensure CRO monitoring activities meet study and regulatory standards
Review CRO monitoring reports, identify trends, and oversee timely resolution of issues
Track monitoring quality metrics and escalate significant compliance or quality concerns to Study Lead
Contributes to the development of protocol, Informed Consent Form, Case Report Forms, and any additional key documents
Maintain internal oversight trackers for site status, recruitment progress, data quality, and monitoring performance
Track vendor deliverables and timelines, escalate issues, and coordinate resolution of site-level queries, study supplies, data entry, and related tasks
Support vendor interactions by ensuring documentation is accurate, study systems are maintained, and site-facing needs are resolved in alignment with study timelines
Build and maintain productive relationships with investigator sites to ensure collaboration, compliance, and data accuracy
Support and guide CRO CRAs, providing additional monitoring training or direction as needed
Participate in CRO calls and ensure alignment on study expectations and performance metrics
Track and evaluate recruitment progress, key metrics across sites, highlighting risks or delays
Track lab samples and turnaround times as needed to support study timelines
Contribute to the development of study materials, such as monitoring plans, oversight tools, recruitment trackers, and training documentation
Collaborate with cross-functional study team members to align timelines, risks, and overall study health
Qualification
Required
Bachelor's degree or equivalent in life sciences or related field required
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
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
Preferred
Additional coursework or certifications in clinical trial planning and operations desired
Priority given to proven experience in CRO oversight and sponsor-level responsibilities
Benefits
Benefits
Stock options
Annual target bonus for full-time positions
Company
Septerna
Septerna is a biotech firm unlocking diverse drug discovery potential in G protein-coupled receptors across various diseases.
Founded in 2022
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
RA Capital ManagementThird Rock Ventures
2024-10-25IPO
2023-09-12Acquired
2023-07-11Series B· $150M
Leadership Team
Jeffrey Finer
CEO and Co-Founder
A
Arthur Christopoulos
Co-Founder
Recent News
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