Sr. Clinical Research Associate
Kezar Life Sciences, United States
Job Description
Kezar Life Sciences is seeking an in-house Sr. Clinical Research Associate to support the planning, executing, driving, and reporting for assigned study(ies). The ideal candidate will be experienced in the successful management of clinical trials in rare diseases on a global level in a start-up environment to support a growing biotechnology company. The expectation is to be onsite at our South San Francisco, CA office at least three days per week.
Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis and autoimmune hepatitis. Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway. This research platform has the potential to generate additional small molecule compounds with therapeutic potential in cancer and inflammation.
Key responsibilities include:
- Supports the Study Lead in the execution of all aspects of clinical trial management.
- Provide regional management which includes oversight of the CRO including but not limited to: enrollment, execution and site issues.
- Provide direct management, and/or oversight of one or more vendors that support the clinical trial.
- Assures compliance with the protocol, regulatory requirements, and quality of data.
- Review CRO monitoring reports and escalate actions items as necessary.
- This is an in-house Sr. CRA role and does not have direct reports and does not have direct site monitoring responsibilities.
- Conduct sponsor oversight monitoring visits as necessary.
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Assists in the creation and updating of study timelines.
- Assists in Contract Resource Organization (CRO) or vendor selection.
- Supports site contract and budget process.
- Assists in review of protocols, informed consents, case report forms and monitoring plans.
- Participates in or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
- Interfaces with individuals in other cross-functional areas to address routine study issues.
- Assists in the training and mentoring of junior CRAs and CTAs.
- Develops processes that increase efficiencies of the project.
- Anticipates obstacles and proactively develops solutions to achieve project goals.
- May oversees site evaluations/initiations and closeout visits in addition to routine monitoring visits.
- Supports Standard Operation Procedure (SOP) processes, development, and improvement.
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
Preferred Qualifications include:
- Bachelor’s Degree or 5 years related work experience in lieu.
- Minimum of 5 years of Clinical Research experience in the pharmaceutical and/or biotechnology industry (including 2+ years direct monitoring experience preferred)
- Global clinical trial experience specifically managing the EU or APAC region preferred. (Remote candidates in the US may be considered to support clinical sites in the EU or APAC.)
- Sound computer skills: proficient in the use of Microsoft Suite; experienced with EDC, IRT, and eTMF systems.
- Ability to apply problem-solving skills to components of the clinical trial process or study issues.
- Strong multi-tasking skills and ability to balance multiple deadlines and competing priorities.
- Strong organizational, communication (oral and written), and interpersonal skills.
- Working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Position may travel up to 20% domestic and/or international for study oversight or investigator meetings that may or may not be inclusive of weekend travel.
Compensation and Benefits
The salary range for this position as Sr. Clinical Research Associate at our South San Francisco, CA corporate office is $125,000 - $135,000. Factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information about our total rewards program can be found here: Join Our Team - Kezar