New

Clinical Research Associate/Senior Clinical Research Associate

South San Francisco, California, United States

 

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.

For more information see: www.septerna.com.

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
  • 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 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.

 

 
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.  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.  Septerna participates in the E-Verify program.  California Consumer Privacy Act Privacy Notice For Job Applicants.  If you are a California resident, click here for our CCPA Notice.

 

Create a Job Alert

Interested in building your career at Septerna? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Septerna’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.