Clinical Research Associate (US East Coast)

Job Summary

Performs site monitoring visits, central monitoring activities, and provides training to sites. Manages budgets, maintains audit readiness, and supports research sites with IRB/EC submissions.

Responsibilities

• Conduct selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work, SOPs, and regulatory requirements.
• May perform Central Monitoring activities and act as primary liaison between site and Central Monitor.
• Works with sites to drive and track subject recruitment, and provide protocol and study-related training.
• Evaluates study site practices and ensures proper conduct of the protocol.
• Ensures informed consent process is properly conducted and documented.
• Leverages expertise in GCP, local regulations, and Alira Health procedures to ensure investigational product (IP) is properly labeled, transported, released, returned, or destroyed.
• Reviews Investigator Site File (ISF) for audit readiness, reconciles ISF with Trial Master File (TMF), and supports audit readiness by submitting documents.
• Supports research sites with IRB/EC submissions and confirms approvals.
• Develops knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.
• Verifies and reviews safety events, reconciling concomitant medications and medical history.
• Assists in setting up and collecting site-specific ethics documents and negotiating contracts.
• Prepares and submits monthly billing information to finance team.
• Manages study budget for stand-alone projects and acts as a reference for the sponsor.
• Prepares accurate monitoring visit reports and communication logs, reporting site-specific concerns, follow-up tasks, corrective actions, protocol deviations, and violations.
• Ensures integrity of source records and case report forms through review and verification for accuracy and completeness.
• Participates in meetings and resolves CRF queries with site staff and data management.
• Conducts audit preparation at study sites as needed.
• Maintains consistency and promotes a collaborative team atmosphere with other CRAs.
• Collaborates with study team members for project execution and performs additional duties as assigned.

Requirements

• Dedicated and results-oriented with a bachelor’s degree in a relevant field (sciences, nursing, medical preferred).
• Experience in the pharmaceutical, health care, biotech, medtech, or CRO industries.
• Experience in computer software and ability to adapt to technology.
• Committed to quality with a proven track record of thoroughness and detail orientation in ensuring protocol adherence and data integrity.
• Organizational and time management skills, enabling effective multitasking in fast-paced environments.
• Team-oriented and flexible, able to prioritize shifting demands and opportunities.
• Strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills to drive successful trial outcomes.
• Willing and able to travel up to 85% to support site visits and project needs, approximately 5-12 days of monitoring per month as appropriate for region of assignment.
• Professional, trustworthy, and disciplined self-starter who thrives in collaborative team settings, fostering a positive and productive atmosphere.
• Skill in establishing and maintaining positive relationships with sponsors, investigative sites, and cross-functional project teams to facilitate seamless communication and achieve study milestones.
• Strong command of English, and the local language as necessary, both written and verbal.
• Able to work in an environment of remote collaborators.
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.

Benefits

Compensation: USD $85,000 - 125,000 commensurate with experience.