17 ago
|
Thermo Fisher Scientific
|
Buenos Aires
17 ago
Thermo Fisher Scientific
Buenos Aires
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
JOIN US AS A CLINICAL RESEARCH ASSOCIATE (CRA / SR. CRA)
AT THERMO FISHER SCIENTIFIC, OUR CLINICAL RESEARCH TEAM SUPPORTS LEADING
PHARMACEUTICAL, BIOTECHNOLOGY, AND EMERGING BIOPHARMA COMPANIES IN ADVANCING
INNOVATIVE THERAPIES WORLDWIDE. HAVING CONTRIBUTED TO THOUSANDS OF CLINICAL
TRIALS ACROSS MORE THAN 100 COUNTRIES, WE ARE COMMITTED TO ACCELERATING RESEARCH
THAT IMPROVES PATIENT LIVES.
AS A CLINICAL RESEARCH ASSOCIATE (CRA), YOU WILL PLAY A KEY ROLE IN THE
MONITORING AND MANAGEMENT OF CLINICAL TRIAL SITES, ENSURING COMPLIANCE WITH
STUDY PROTOCOLS, ICH-GCP GUIDELINES, REGULATORY REQUIREMENTS, AND COMPANY
PROCEDURES. WORKING CLOSELY WITH INVESTIGATIVE SITES AND CROSS-FUNCTIONAL TEAMS,
YOU WILL HELP SAFEGUARD PATIENT SAFETY, DATA INTEGRITY, AND OVERALL STUDY
QUALITY WHILE SUPPORTING THE SUCCESSFUL DELIVERY OF CLINICAL RESEARCH PROGRAMS.
POSITION SUMMARY
AS A CLINICAL RESEARCH ASSOCIATE (CRA), YOU WILL BE RESPONSIBLE FOR PERFORMING
AND COORDINATING CLINICAL MONITORING AND SITE MANAGEMENT ACTIVITIES ACROSS
CLINICAL TRIALS. YOU WILL CONDUCT REMOTE AND ON-SITE MONITORING VISITS, ENSURE
COMPLIANCE WITH STUDY PROTOCOLS, ICH-GCP GUIDELINES, APPLICABLE REGULATIONS, AND
SOPS, WHILE SAFEGUARDING SUBJECT SAFETY, DATA INTEGRITY, AND AUDIT READINESS.
YOU WILL COLLABORATE CLOSELY WITH INVESTIGATIONAL SITES, SPONSORS, AND
CROSS-FUNCTIONAL PROJECT TEAMS TO SUPPORT THE SUCCESSFUL EXECUTION OF CLINICAL
STUDIES.
KEY RESPONSIBILITIES:
* CONDUCT ON-SITE AND REMOTE MONITORING VISITS USING A RISK-BASED MONITORING
APPROACH.
* REVIEW SOURCE DOCUMENTATION, CASE REPORT FORMS (CRFS), AND STUDY DATA TO
ENSURE ACCURACY, COMPLETENESS, AND COMPLIANCE.
* PERFORM SITE MANAGEMENT ACTIVITIES, INCLUDING SITE INITIATION, ROUTINE
MONITORING, AND CLOSE-OUT VISITS.
* ASSESS INVESTIGATIONAL PRODUCT ACCOUNTABILITY THROUGH INVENTORY AND RECORDS
REVIEW.
* IDENTIFY SITE PROCESS ISSUES, PERFORM ROOT CAUSE ANALYSIS, A
📌 CRA / Sr CRA (Buenos Aires)
🏢 Thermo Fisher Scientific
📍 Buenos Aires