Clinical Research Associate

Overview Our company 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. Integrity, knowledge, imagination, skill, diversity and teamwork are the foundation of excellence. We strive to create an environment of mutual respect, encouragement and teamwork, offering talented and dedicated colleagues the opportunity to collaborate and grow their careers. Role Summary This Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in Argentina. Under the oversight of the CRA manager, the person ensures compliance with ICH/GCP, country regulations, company policies and procedures, quality standards and adverse event reporting requirements. The role serves as the primary site contact and site manager throughout all phases of a clinical research study, takes overall responsibility of allocated sites, actively develops new site territory, and participates in internal meetings as a subject‑matter expert for monitoring processes and systems. Main Responsibilities Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, local laws & regulations, protocol, Site Monitoring Plan and associated documents. Gains an in‑depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on‑site monitoring & oversight activities using various tools to ensure data quality, subject safety and compliance. Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well‑being are protected. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close‑out visits and records clear, comprehensive and accurate visit & non‑visit contact reports promptly. Collects, reviews, and monitors required regulatory documentation for study start‑up, maintenance and close‑out. Communicates with investigators and site staff on protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections and overall site performance. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway in collaboration with CRA manager, CRM, and RCPM. Manages and maintains information and documentation in CTMS, eTMF and other systems per timelines. Contributes to CRA team knowledge by acting as process SME, buddy/mentor and sharing best practices as appropriate. Supports and/or leads audit/inspection activities as needed. Follows country strategy to identify new potential sites and develops strong clinical research capabilities. Core Competency Expectations Fluent in English (verbal and written) and excellent communication skills. Good understanding and working knowledge of clinical research, phases of trials, GCP/ICH & country guidelines. Hands‑on knowledge of Good Documentation Practices. Proven skills in site management including performance and patient recruitment. High level of monitoring skill with independent professional judgment. Good IT skills and ability to adapt to new applications across devices. Ability to understand and analyse data/metrics and act appropriately. Effective time management, organizational and interpersonal skills. Conflict management and problem‑solving skills. Ability to work highly independently across multiple protocols, sites and therapy areas. High sense of accountability / urgency; sets priorities and handles multiple tasks simultaneously. Works effectively in a matrix multicultural environment; maintains culturally sensitive relationships. Demonstrates commitment to customer focus and compliance mindset. Qualifications & Experience Min. 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. Required Skills Accountability Adverse Event Report Clinical Evaluation Reports Clinical IT Clinical Research Methods Clinical Site Management Clinical Study Management Clinical Trials Data Management Documentations Early Clinical Development Electronic Data Capture (EDC) Finance Good Clinical Data Management Practice (GCDMP) Investigations Training Key Performance Indicators (KPI) Maintenance Processes Medical Research Patient Recruitment Performance Monitoring Pharmaceutical Guidelines Pharmacovigilance Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE Benefits Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. #J-18808-Ljbffr