Site Research Assistant - Fixed Term
Buenos Aires, Argentina
hace 4 días

Job Overview

Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and / or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP).

Assist with daily workload planning.

Essential Functions :

  • Provide clinical research support to investigators to prepare for and execute assigned research studies.
  • Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data.
  • Collect and submit regulatory / ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
  • Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness.
  • Recruit and screen patients for clinical trials and maintain subject screening logs.
  • Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics.
  • Monitor subject safety and report adverse reactions to appropriate medical personnel.
  • Assist with study data quality checking and query resolution.
  • Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
  • Schedule and execute study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
  • Assist research site with coverage planning related to staffing and scheduling for research projects.
  • Qualifications :

  • Bachelor's degree in life sciences or related field.
  • Desirable work experience in a clinical environment.
  • Working knowledge of Clinical Trials and the principles of Good Clinical Practices (GCP)
  • English Level : Intermediate.
  • 6 months Fixed Term Contract.
  • Locations : CABA, Mar del Plata, Córdoba Capital and San Miguel de Tucuman.
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