Clinical Research Associate II (Clinical Trial Operations)

10 Nov 2024

Vacancy expired!

Job Description

The Clinical Research Associatell (CRA) is responsible for management and monitoring activities that will lead to successful execution of IVDclinical studies. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. The CRA engages with internal and external stakeholders as a member of the Clinical Trial Operations team.

Essential Duties/Responsibilities:

  • Responsible for all aspects of study site monitoring including pre-study, initiation, interim, and close-out monitoring visits of clinical sites.
  • Involved in the development of study protocols, reports, and data transfer specifications (DTS.
  • Manage or coordinate all aspects of the clinical monitoring process in compliance with GCP/ICH guidelines and regulations including review of all required essential documents necessary for study initiation to ensure audit ready study files throughout the duration of the study.
  • Manage the identification, selection and feasibility processes.
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions.
  • Prepare accurate and timely trip reports.
  • Maintain and document professional communication with the study sponsor, clinical sites, cross functional project team and management throughout the duration of the study.
  • Participates in the development and maintaining of standard operating procedures.
  • Manages material logistics and acts as contact for clinical trial supplies and other suppliers (vendors) as assigned
  • Ensures accurate and complete study management/data collection and transfer to data management
  • Assists, prepares and manages study timelines.
  • Acquires a basic understanding of the principles of the assay and/or instrument and "hands-on" knowledge.
  • Actively participates as a member of the cross-functional project team.
  • Maintains accurate and timely sponsor/site correspondence and communication.
  • Prepares and presents project progress reports to keep management and team informed.
  • Implements all policies, established procedures, and regulations into daily operations as appropriate. Develops professional, expertise via professional and educational opportunities.

Skills:

  • Demonstrates basic writing skills. (i.e. clear, concise, effective, and well-organized)
  • Tries to understand changes in work tasks, situations, and environment as well as the logic or basis for change.
  • The ability to thrive with minimal supervision
  • The ability to drive aa resolution for project-related problems while prioritizing workload
  • Efficient and effective work habits in a matrix environment, internally and externally.
  • A flexible attitude to adjust to changing needs
  • Excellent knowledge of MS Office as well as project management and clinical trials software.

Qualifications

  • Minimum Bachelor's degree B.S in biological sciences or medical specialty preferred.
  • Minimum of 3 years’ experience in clinical research, in-vitro diagnostics, CLIA laboratory
  • Preferred knowledge of regulations (CFR / GCP) and standards (ICH) affecting IVDs
  • Preferred site monitoring of in vitro diagnostic device trials or clinical laboratory assay/instrument experience.
  • Preferred oncology experience
  • Other: Clinical Laboratory certification (MT,ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable.

Covid Vaccination Policy:Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation.Anemployee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this Policy by obtaining, if applicable, any FDA-approved boosters.

Additional Information

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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  • ID: #22528993
  • State: California Redwoodcity 94061 Redwoodcity USA
  • City: Redwoodcity
  • Salary: USD TBD TBD
  • Job type: Full-time
  • Showed: 2021-11-10
  • Deadline: 2022-01-07
  • Category: Et cetera