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

Location Requirements

The candidate must reside in one of the following locations:
Illinois, Colorado, South Florida, New York, California, Houston, Dallas.

• Accountable for performance and compliance for assigned protocols and sites in a country.
• Under the oversight of the CRA‑Manager ensures compliance of study conduct with ICH/GCP, country regulations, company policies, quality standards and adverse event reporting requirements.
• Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Actively develops and expands the territory for clinical research by finding and developing new sites.
• Participates in internal meetings and work streams as subject matter expert for monitoring processes and systems.
• 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 and provides inputs on site selection and validation activities.
• Performs remote and on‑site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased; subjects’ rights, safety and well‑being are protected.
• Conducts site visits including validation, initiation, monitoring and close‑out visits and records clear, comprehensive and accurate visit & non‑visit contact reports in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start‑up, study maintenance and study close‑out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site 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 the CRA‑Manager, CRM, TA Head and CRD as needed.
• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities to support assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and other systems as appropriate and per timelines.
• Contributes to CRA team knowledge as process subject matter expert, buddy/mentor and shares best practices.
• Supports and/or leads audit/inspection activities as needed.
• Performs co‑monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA‑Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

• Approximately 65-75% domestic and international travel; expected 2-3 days per week.
• Current driver's license required.

• Fluent in local languages and English (verbal and written) with excellent communication skills.
• Good understanding of clinical research phases, current GCP/ICH & local clinical research law & guidelines.
• Good understanding of global, country/regional guidelines and ability to work within them.
• Hands‑on knowledge of Good Documentation Practices.
• Proven skills in site management including management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (MS Office, various clinical IT applications on computer, tablet and mobile devices).
• Ability to understand and analyze data/metrics and act appropriately.
• Capable of managing complex issues, works in a solution‑oriented manner.
• Performs root cause analysis and implements preventative and corrective action.

• Effective time management, organizational and interpersonal…