Clinical Research Associate (CRA) - C in Santa Clara, CA at Volt

Date Posted: 9/24/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Job Type:
  • Duration:
    36 weeks
  • Date Posted:
    9/24/2020
  • Job ID:
    244867
  • Contact Name
    Volt Branch
  • Phone
    714-921-7429

Job Description

Description:

The Clinical Research Associate will be part of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines.

Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Design, implement, and monitor clinical studies of new and modified in vitro diagnostic products.
  • Ensures that the clinical studies are designed to validate product performance claims and support the products’ intended use.
  • Prepares clinical data reviews and data summaries.
  • Participates in the preparation of regulatory submissions and international registration packages.
  • Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
  • Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.

Qualifications:

  • Minimum Bachelor's degree B.S in biological sciences or medical specialty preferred.
  • Knowledge of regulations and standards (GCP) affecting IVDs and Biologics.
  • Other: Clinical Laboratory certification (MT,ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable.  
  • Minimum of 3 years clinical related experience Preferred site monitoring of investigational drug or device trials or clinical laboratory assay/instrument experience.

Volt is an equal opportunity employer.