Clinical Research Associate

4 weeks ago


South San Francisco, United States Centivax Full time
Job DescriptionJob Description

Responsibilities:

  • As a vital member of our clinical team, the Clinical Research Associate will be responsible for conducting Phase I-IV single or multi-center studies in adherence to Federal Regulations and ICH guidelines.

Key responsibilities include:

  • Collaborating with senior staff in planning study conduct.
  • Designing case report forms (CRFs) and managing Contract Research.
  • Organization (CRO) selection.
  • Selecting and training investigator sites, planning and organizing study meetings.
  • Evaluating, selecting, and training new study investigators.
  • Writing and assembling submissions related to study protocols.
  • Monitoring investigational sites to ensure protocol adherence.
  • Ensuring timely enrollment of patients and retrieval of CRFs from study sites.
  • Processing CRFs, including data cleanup and classification of data.
  • Completing study summaries and reports.

Experience:

  • The ideal candidate should possess a minimum of 2 years of experience in clinical research monitoring.

Key qualifications include:

  • Proven experience in the successful execution and monitoring of clinical trials.
  • Familiarity with Federal Regulations and ICH guidelines.
  • Strong attention to detail and organizational skills.
  • Ability to work effectively within a collaborative team environment.
  • Experience with vaccines against infectious diseases clinical trials highly desired but not absolutely necessary.

Education:

  • A minimum of an Associate degree is required, but preference will be given to candidates with a Bachelor's degree.
  • Additionally, candidates should have at least 2 years of monitoring experience with preference on vaccines against infectious diseases clinical trials.

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