Clinical Research Associate​/Senior Clinical Research Associate

Clinical Research Associate/Senior Clinical Research Associate

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.

The CRA/Senior CRA at Septerna plays a crucial part by leading various aspects of Sponsor oversight activities related to monitoring of our clinical trials. The CRA/Senior CRA partners with the Clinical Trial Associate and Sr. CTM to provide overall support in matters related to investigational site management, site relationship building, site compliance, study timelines, high data quality, inspection readiness and other study related activities, including study start-up, interim study monitoring as well as trial closeout activities.

This position offers significant opportunities for professional growth
, with potential to expand responsibilities in clinical operations leadership, CRO management, and strategic study oversight as the organization and the company’s clinical pipeline continues to evolve.

Responsibilities:

Clinical Oversight

• 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

Site & CRO Relationship Management

• 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.

Recruitment Oversight & Support

• Track and evaluate recruitment progress, key metrics across sites, highlighting risks or…