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Clinical Research Associate MSD LATAM is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Job Overview The role is accountable for performance and compliance for assigned protocols and sites in Argentina. Under the oversight of the CRA manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards, and adverse event reporting requirements. The CRA acts as the primary site contact and site manager throughout all phases of a clinical research study. Main Responsibilities Develop strong site relationships and ensure continuity through all phases of the trial. Perform clinical study site management/monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, local laws & regulations, protocol, Site Monitoring Plan and associated documents. Gain an in‑depth understanding of the study protocol and related procedures. Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Ready. Participate & provide inputs on site selection and validation activities. Perform remote and on‑site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate, and unbiased. Ensure subjects’ rights, safety and well‑being are protected. Conduct site visits – validation, initiation, monitoring, close‑out – and record clear, comprehensive and timely visit & non‑visit contact reports. Collect, review, and monitor required regulatory documentation for study start‑up, maintenance and close‑out. Communicate with investigators and site staff on issues related to protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections and overall site performance. Identify, assess and resolve site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway in collaboration with CRA manager, CRM, and RCPM. Manage and maintain information and documentation in CTMS, eTMF and other systems as appropriate. Contribute to CRA team knowledge by acting as process SME, mentor and sharing best practices. Support and/or lead audit/inspection activities as needed. Following the country strategy defined by CRD and CRA manager, contribute to the identification of new potential sites and work closely with them to develop strong clinical research capabilities. Core Competency Expectations Fluent in English (verbal and written) with excellent communication skills. Good understanding of clinical research phases, GCP/ICH, and country clinical research law & guidelines. Experience with Good Documentation Practices and global/regional guidelines. Proven skills in site management, site performance, and patient recruitment. High level of monitoring skill with independent professional judgment. Good IT skills – use of MS Office, various clinical IT applications on computer, tablet and mobile devices. Ability to understand and analyse data/metrics and act appropriately. Effective time management, organizational and interpersonal skills, conflict management, problem‑solving. Ability to work highly independently across multiple protocols, sites and therapy areas. High sense of accountability/urgency; ability to set priorities and handle multiple tasks simultaneously. Works effectively in a matrix multicultural environment and establishes culturally sensitive working relationships. Demonstrates commitment to customer focus. High quality and compliance mindset. Requirements Minimum 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Fluent in English (verbal and written). B.A./B.S. with strong emphasis in science and/or biology. Benefits Our employees are the key to our company’s success. We demonstrate our commitment by offering a competitive benefits program designed to support a wide range of goals, needs and lifestyles. Employment Details Seniority Level: Not Applicable Employment Type: Full‑time Job Function: Research, Science, and Health Care Provider Industries: Biotechnology Research, Pharmaceutical Manufacturing, Veterinary Services Employee Status: Regular Relocation: No VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): No Additional Information Recruitment is open for residents of Buenos Aires, Buenos Aires Province, Argentina. Requisition ID: R Job Posting End Date: 11/13/2025 (A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date. Please apply no later than the day BEFORE the end date.) #J-18808-Ljbffr