Sr. Clinical Research Associate; CRA- Early Stage Development; ESD Remote

Job Summary

CANDIDATE MUST RESIDE IN FLORIDA. Early stage development experience required.

Accountable for performance and compliance for assigned protocols and sites in a country, ensuring compliance with ICH/GCP, local regulations, company policies and adverse event reporting. Acts as primary site contact and manager throughout all phases, actively developing and expanding the territory for clinical research.

• Develop strong site relationships and ensure continuity through all trial phases.
• Perform clinical study site management and monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, local laws, protocol, and the Site Monitoring Plan.
• 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 and provide inputs on site selection and validation activities.
• Conduct remote and on‑site monitoring and oversight activities using various tools to ensure data integrity and subject safety.
• Perform validation, initiation, monitoring, and close‑out visits; record clear, comprehensive, and timely visit and 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 protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and overall performance.
• Identify, assess, and resolve site performance, quality, or compliance problems; collaborate with CRA‑Manager, CRM, TA Head, and CRD on escalation.
• Work in partnership with internal teams (GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functions) and external stakeholders (vendors, IRB/IECs, regulatory authorities).
• Maintain information and documentation in CTMS, eTMF, and other systems per timelines.
• Act as a process Subject Matter Expert, sharing best practices, recommending improvements, and providing training.
• Support and/or lead audit/inspection activities as needed.
• Identify and develop new potential sites in accordance with the country strategy.
• Mentor junior CRAs and perform co‑monitoring visits where appropriate.
• Perform quality control visits if delegated and trained appropriately.
• Travel domestically and internationally approximately 65–75% of work time (≈2–3 days per week); valid driver’s license required.

• Associate’s degree, certificate, or equivalent in a scientific or healthcare discipline with at least 7 years of healthcare experience, including ≥4 years of direct site management in bio/pharma/CRO (early‑stage development experience required).
• Bachelor’s degree or higher with at least 4 years of direct site management in bio/pharma/CRO (early‑stage development experience required).
• Fluent in local languages and English (verbal and written).
• Excellent communication skills; ability to present technical information effectively.
• Strong understanding of clinical research phases, GCP/ICH, and country clinical research laws and guidelines.
• Proven ability to mentor/lead and perform independent site management.
• Hands‑on knowledge of Good Documentation Practices.
• Proficient with MS Office and clinical IT applications on desktop, tablet, and mobile devices.
• Analytical skills to interpret data/metrics and act appropriately, including in virtual environments.
• Experience in conducting site motivational visits to boost enrollment.
• Capability to manage complex issues, perform root‑cause analysis, and implement corrective actions.

• High level of monitoring skill with independent professional judgment.
• Problem‑solving, conflict management, time management, and organizational skills.
• Independent work across multiple protocols, sites, and therapy areas.
• Accountability and urgency; ability to set priorities in changing environments.
• Effectiveness in a matrix multicultural environment and sensitivity to cultural differences.
• Professional demeanor and communication consistent with company policies.

• Salary range: $ – $.
• Eligible for annual bonus and long‑term incentive if applicable.
• Comprehensive benefits…