Clinical Research Associate II

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in identifying potential investigative sites and perform site qualification visits.

• Gather and examine site regulatory documents and create site qualification reports.

• Engage in the final selection process of investigative sites.

• Carry out site initiation visits and train site personnel on client and regulatory requirements.

• Participate in or facilitate site and investigator meetings.

• Execute site monitoring visits and address significant problems and issues.

• Ensure clinical studies adhere to study plans, GCPs, and relevant regulations.

• Review on-site files, records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance.

• Identify deficiencies and discrepancies, initiating corrective actions as needed.

• Assist in submissions to Independent Ethics Committees and Competent/Regulatory Authorities.

• Organize site payments and support site budgets and contracts.

• Ensure training is timely, current, and properly documented.

• Document protocol deviations and ensure action items are completed.

• Manage monitoring visit schedules and follow up on issues between visits.

• Maintain consistent communication with site staff and the clinical study team.

• Monitor patient enrollment, enrolled patient statuses, investigational product supply, and site requests or issues.

• Ensure essential documents are properly filed in the Trial Master File.

• Guarantee timely transmission of clinical data to data management.

• Review data queries and clarify or obtain necessary data changes.

• Conduct site close-out visits, including final investigational product reconciliation and disposition.

• Review file completeness and accuracy, retrieving documents for the Trial Master File.

• Prepare reports for site close-out visits.

• Attend team meetings as required.

• Participate in systems User Acceptance Testing as needed.

• Perform additional duties as assigned.

⛳️ Requirements

• Demonstrated experience in clinical research monitoring and site management.

• Strong understanding of the clinical research process, clinical trial-related systems and procedures, regulations, and GCPs.

• Scientific or clinical knowledge sufficient to comprehend the nature of the drugs being studied.

• Exceptional written and verbal communication, time management, organizational, and problem-solving abilities.

• Fluency in the local language, both spoken and written.

• Good understanding of English in regions where it is not the local language.

• Excellent interpersonal skills and the ability to thrive in a matrixed team environment.

• Commitment to quality in all tasks and deliverables.

• Capable of prioritizing and managing multiple tasks, including during travel and monitoring visits.

• Proficient in computer systems, applications, and operating systems.

• Willingness to travel up to 75% of the time.

• Valid driver's license, as necessary.

• Degree in Life Sciences, nursing background, or equivalent education and experience, along with successful completion of a recognized CRA training program.

• Proven monitoring and site management experience.

• Ability to endure prolonged periods of sitting at a desk and working on a computer.

• Capability to travel by car, air, or train as needed for job support.

🏝️ Benefits

• PTO

• Comprehensive benefits