Clinical Research Associate II

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

📋 Description

• Engage in identifying potential investigative sites, conduct site qualification visits, assess site regulatory documents, and prepare site qualification reports and related documentation.

• Take part in the final selection process of investigative sites.

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

• Participate in or lead site and investigator meetings, preparing associated reports.

• Carry out site monitoring visits and follow up to identify issues, ensuring compliance with study plans, GCPs, and relevant regulations.

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

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

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

• Organize site payments and facilitate site budgets and contracts as required.

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

• Document protocol deviations and ensure action items are addressed.

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

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

• Monitor patient enrollment, the status of enrolled patients, investigational product supply, and address site requests or issues.

• Ensure essential documents are filed in the Trial Master File according to project guidelines.

• Guarantee timely transmission of clinical data to data management and review and resolve data queries.

• Conduct site close-out visits, which include final investigational product reconciliation, file review, and document retrieval for the Trial Master File.

• Prepare site close-out reports and documentation.

• Attend team meetings as required.

• Participate in systems User Acceptance Testing as needed.

• Perform additional duties as assigned.

• Report to the Senior Manager of Site Management and Monitoring.

⛳️ Requirements

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

• Proven experience in monitoring and site management.

• In-depth understanding of the clinical research process, clinical trial-related systems and procedures, regulations, GCPs, and the scientific/clinical knowledge necessary to comprehend the nature of drugs being studied.

• Exceptional written and verbal communication skills.

• Strong time management, organizational, and problem-solving abilities.

• Proficiency in the local language (both spoken and written) and good comprehension of English where English is not the primary language.

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

• Commitment to quality in all tasks and deliverables.

• Capability to prioritize and manage multiple tasks, including during travel and monitoring visits.

• Proficient knowledge of computer systems, applications, and operating systems.

• Willingness to travel up to 75%.

• Valid driver's license, if required.

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

• Ability to travel by car, air, or train as necessary to fulfill job responsibilities.

🏝️ Benefits

• Paid Time Off (PTO)

• Comprehensive benefits package