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Clinical Research Associate
Company: Kezar Life Sciences
Location: South San Francisco, CA
Employment Type: Full Time
Date Posted: 07/22/2021
Expire Date: 09/22/2021
Job Categories: Biotechnology and Pharmaceutical
Job Description
Clinical Research Associate
Kezar Life Sciences (NASDAQ: KZR), a clinical stage biopharmaceutical company located in South San Francisco, is seeking a Clinical Research Associate to join our team. Kezar is focused on small molecule drug discovery and development to target autoimmune/inflammatory disorders and cancer based on the biology of protein homeostasis. Our lead compound, KZR-616, a selective inhibitor of the immunoproteasome, is in early-stage clinical trials. In addition, we have multiple drug discovery programs targeting protein secretion to include multi-indication small molecule programs that take aim at known and novel therapeutic targets subject to protein homeostasis. This position provides an exciting opportunity for major scientific and strategic roles in the research and development of novel therapies for serious diseases.

Responsibilities:
- Collaborate with cross-functional teams to oversee and support activities dedicated to study execution
- Contribute to clinical study documentation including clinical protocols and study plans
- Coordinate and participate in specified clinical trial meetings (investigator meetings, study team meetings, CRO meetings); arrange logistics, prepare materials and record/distribute minutes as needed
- Participate in the selection and oversight of vendors
- Maintain effective relationships with clinical collaborators and clinical site personnel
- May act as a Protocol Lead for smaller, less complex clinical trials; or may oversee a geographical region for a larger, global clinical trial
- Assist with the management of clinical trial supplies
- Track and report progress of study, including patient screening/enrollment data from a variety of systems and sources
- Review data in EDC to ensure data is being entered in a timely manner and escalate issues as appropriate
- Perform review of monitoring visit reports and ensure issues are being addressed in a timely manner; escalate as appropriate
- Assist Data Management in the development of case report forms
- Perform data listing reviews per role defined in Data Review Plan
- Coordinate, track and manage quality control, vendor utilization and shipping of clinical samples
- Analyze information, and utilize prior clinical experience and problem-solving skills to ensure the best possible outcome for the clinical research program
- Position may include up to 20% domestic and/or international travel for monitoring oversight visits, however, this is considered to be an ‘in-house’ position and is not a field monitoring one

Requirements:
- Bachelor’s degree in a scientific field
- 2+ years of relevant clinical trial experience (preferably on the sponsor-side). Note: the level of CRA will be dependent upon years and type of previous experience.
- Preferred experience in autoimmune/inflammatory diseases
- Sound computer skills: proficient in the use of Excel, Word, Project and PowerPoint; experienced with EDC systems; an aptitude for being able to train rapidly on new systems and facilitate the deployment of such systems to broader audiences. Competent in an electronic environment and the handling of documentation in such environments.
- Ability to work with initiative and independence while exercising appropriate judgement when direction is required
- Comfortable working in a start-up environment and a desire to help build process
- Thorough knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs

Skills:
- Attention to detail
- Ability to interact appropriately with clinical site personnel, and vendors, negotiating and motivating in a professional manner to achieve the right objectives
- Strong organizational, communication (oral and written), and interpersonal skills
- Time management, planning and project management skills
- An understanding of documentation management and document control workspaces (principles of audit trail and permissions control)
- Multi-tasking skills and ability to manage multiple competing tasks, tracking multiple deadlines and competing activities
Contact Information
Website: https://apply.workable.com/kezar/j/...
Company Description:
Founded in 2015 and based in South San Francisco, Kezar (pronounced “keys are”) Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders – with the hope of helping people overcome their disease and live a better life. We are pioneering first-in-class, small molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. We are translating our innovative research in protein degradation (via immunoproteasome inhibition) and protein secretion (via the Sec61 translocon) to have a significant clinical impact in the most difficult-to-treat diseases.
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