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.
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.