Clinical Research Associate​/Senior Clinical Research Associate

THE ROLE

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. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs.

Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals;

and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.

We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the front lines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.

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• 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 elevate significant compliance or quality concerns to Study Lead.
• Contribute 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, elevate 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.

• 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 initiative to find solutions.
• Experience in site selection,…