Job Details

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 frontlines 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.

About the Role

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

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 delays.
• Track lab samples and turnaround times as needed to support study timelines

Cross-Functional Collaboration

• 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.

Qualifications

• 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 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
• Priority given to proven experience in CRO oversight and sponsor-level responsibilities.

Knowledge, Skills and Abilities

• 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

The anticipated salary range for candidates who will work in South San Francisco, CA is $130,000 - $160,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.