Clinical Research Associate
- Employer
- Kezar Life Sciences
- Location
- South San Francisco, CA
- Closing date
- Oct 15, 2022
View more
- Sector
- Pharmaceutical, Clinical Research Associate
- Organization Type
- Corporate
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Job Description
Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking an in-house Clinical Research Associate (CRA). The CRA will 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.
Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezars lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated for the treatment of severe autoimmune diseases. KZR-261, Kezars first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.
RESPONSIBILITIES
Supports the Sr. CRA and Study Lead in the execution of all aspects of clinical trial management
Collaborates with cross-functional teams
Participates in meetings and conference calls with CROs, vendors and cross-functional teams
Coordinates specified clinical trial meetings (study team, CRO, etc.), prepares materials and may record/distribute minutes
Participates in the selection of vendors, CROs and Investigators
Effectively manages assigned vendors
Participates in the development and review of protocols, informed consents, case report forms and various study plans.
Reviews data and assists in the resolution of data discrepancies.
Participates in the oversight of site monitoring visits (SQV, SIV, IMV, COV)
Develops tools to increase efficiencies of the project
Ensures necessary study supplies are available at sites, coordinating with vendors as needed
Supports the site contract and budget negotiation process
Creates and updates effective tracking tools to support the study
Position may travel up to 20% domestic or internationally for study oversight or investigator meetings, however, this role is an in-house position and does not have direct site monitoring responsibilities
REQUIREMENTS
Bachelors degree in a scientific field or equivalent in a relevant scientific or related discipline
2+ years of clinical research experience (preferably on the sponsor-side)
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.
Must have a general understanding of cross functional clinical issues and routine project goals Thorough knowledge of ICH/GCP guidelines and FDA requirements
Kezar Life Sciences is an Equal Opportunity Employer
Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking an in-house Clinical Research Associate (CRA). The CRA will 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.
Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezars lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated for the treatment of severe autoimmune diseases. KZR-261, Kezars first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.
RESPONSIBILITIES
Supports the Sr. CRA and Study Lead in the execution of all aspects of clinical trial management
Collaborates with cross-functional teams
Participates in meetings and conference calls with CROs, vendors and cross-functional teams
Coordinates specified clinical trial meetings (study team, CRO, etc.), prepares materials and may record/distribute minutes
Participates in the selection of vendors, CROs and Investigators
Effectively manages assigned vendors
Participates in the development and review of protocols, informed consents, case report forms and various study plans.
Reviews data and assists in the resolution of data discrepancies.
Participates in the oversight of site monitoring visits (SQV, SIV, IMV, COV)
Develops tools to increase efficiencies of the project
Ensures necessary study supplies are available at sites, coordinating with vendors as needed
Supports the site contract and budget negotiation process
Creates and updates effective tracking tools to support the study
Position may travel up to 20% domestic or internationally for study oversight or investigator meetings, however, this role is an in-house position and does not have direct site monitoring responsibilities
REQUIREMENTS
Bachelors degree in a scientific field or equivalent in a relevant scientific or related discipline
2+ years of clinical research experience (preferably on the sponsor-side)
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.
Must have a general understanding of cross functional clinical issues and routine project goals Thorough knowledge of ICH/GCP guidelines and FDA requirements
Kezar Life Sciences is an Equal Opportunity Employer
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