Clinical Research Associate; CRA - Cardiovascular​/Vaccine​/Infectious Disease- Remote

Job Overview

Clinical Research Associate (CRA) responsible for performance and compliance of assigned protocols and sites in a country. Must reside in Illinois, Colorado, South Florida, New York, California, Houston, or Dallas. Under CRA‑Manager oversight, ensures compliance with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting. Acts as primary site contact and manager throughout all research phases, taking overall responsibility for allocated sites and actively expanding the territory by finding and developing new sites.

• Develop and maintain strong site relationships, ensuring continuity through all trial phases.
• Perform site management and monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, local laws and regulations, protocol, site monitoring plan, and related documents.
• Gain an in‑depth understanding of the study protocol and related procedures.
• Coordinate and manage tasks with sponsor roles to achieve Site Ready status.
• Participate in site selection and validation activities.
• Conduct remote and on‑site monitoring, ensuring data completeness, accuracy, and bias‑free generation while protecting subjects’ rights and safety.
• Execute site visits (validation, initiation, monitoring, close‑out) and record comprehensive, accurate visit and non‑visit contact reports promptly.
• Collect, review, and monitor required regulatory documentation for study start‑up, maintenance, and close‑out.
• Communicate with investigators and site staff on protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and overall performance.
• Identify, assess, and resolve site performance, quality, or compliance issues, escalating per CRA escalation pathway in collaboration with CRA‑Manager, CRM, TA Head, and CRD.
• Partner with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functional areas, vendors, IRB/IECs, and Regulatory Authorities to support assigned sites.
• Maintain and update information and documentation in CTMS, eTMF, and other systems per timelines.
• Contribute to CRA team knowledge as a subject matter expert, mentor, and best‑practice sharer.
• Support and/or lead audit/inspection activities as needed.
• Perform co‑monitoring visits where appropriate.
• Identify new potential sites in line with the country strategy defined by CRD and/or CRA‑Manager, working closely to develop strong clinical research capabilities.

Travel: approximately 65%‑75% of working time, including domestic and international trips (~2‑3 days per week). Current driver’s license required.

• Fluent in local language(s) and English, with excellent communication skills.
• Good understanding of clinical research phases, GCP/ICH, and country guidelines.
• Knowledge of global, country, and regional research guidelines.
• Hands‑on knowledge of good documentation practices.
• Proven skills in site management, performance oversight, and patient recruitment.
• High level of monitoring skill with independent professional judgment.
• Good IT skills, including MS Office and clinical IT applications on desktop, tablet, and mobile.
• Ability to analyze data/metrics and act appropriately.
• Capability to manage complex issues, work solution‑oriented, and perform root cause analysis with corrective action.

• Effective time management, organizational, interpersonal, and conflict‑management skills.
• Problem‑solving ability and independent work across multiple protocols and sites.
• High sense of accountability and urgency; ability to set priorities and handle multiple tasks in a changing environment.
• Capability to work effectively in a matrix multicultural environment and establish culturally sensitive relationships.
• Customer‑focus, quality‑ and compliance‑mindset, positive and growth mindset.
• Professional demeanor and consistent communication aligned with organizational policies.

Associate’s degree or higher in a scientific or healthcare discipline with at least 5 years of relevant experience and 2 years of direct site…