Clinical Research Associate – FSP

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

📋 Description

• Build robust relationships with site personnel and ensure seamless continuity throughout all phases of the trial.

• Execute clinical study site management and monitoring in accordance with ICH/GCP, sponsor SOPs, local laws and regulations, as well as protocol, site monitoring plans, and related documents.

• Acquire a comprehensive understanding of study protocols and associated procedures.

• Organize and manage tasks alongside sponsor roles to facilitate site readiness.

• Engage in site selection and validation processes.

• Conduct both remote and on-site monitoring to guarantee complete, accurate, and objective site data while safeguarding the rights, safety, and well-being of participants.

• Carry out validation, initiation, monitoring, and closeout visits.

• Produce clear, thorough, and precise visit and non-visit contact reports.

• Gather, review, and oversee regulatory documentation for study initiation, maintenance, and closure.

• Liaise with investigators and site personnel regarding protocol implementation, recruitment, retention, protocol deviations, regulatory documents, audits, inspections, and site performance.

• Identify, evaluate, resolve, and escalate issues related to site performance, quality, and compliance.

• Maintain accurate information and documentation in clinical trial management systems, electronic trial master files, and other platforms.

• Contribute to the CRA team’s knowledge as a process expert, mentor, or buddy.

• Assist or lead audit and inspection activities.

• Conduct co-monitoring visits when appropriate.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Ensure compliance with Parexel/client processes, ICH-GCP, and relevant requirements.

⛳️ Requirements

• Proficient in local languages and English, both spoken and written.

• Exceptional communication abilities, including effectively conveying and presenting technical information.

• Solid understanding and practical knowledge of clinical research and the phases of clinical trials.

• Familiarity with current GCP/ICH and local clinical research laws and guidelines.

• Comprehension of global and country/regional clinical research guidelines.

• Practical knowledge of Good Documentation Practices.

• Proven expertise in site management, encompassing site performance and patient recruitment.

• Demonstrated high-level monitoring skills coupled with independent professional judgment.

• Proficient in IT skills, including MS Office and clinical IT applications on computers, tablets, and mobile devices.

• Capability to understand and analyze data/metrics and respond appropriately.

• Aptitude for managing complex issues with a solution-oriented approach.

• Experience in root cause analysis and implementing preventive/corrective actions.

• Strong time management, organizational, interpersonal, conflict resolution, and problem-solving skills.

• Ability to work independently across multiple protocols, sites, and therapeutic areas.

• Skill in prioritizing and handling multiple tasks in a dynamic environment.

• Capacity to work effectively in a multicultural matrix environment and maintain culturally sensitive working relationships.

• Customer-focused with a strong quality and compliance mindset.

• Positive and growth-oriented attitude; self-motivated and able to work independently.

• Professional demeanor and communication aligned with organizational policies and practices.

• Willingness to travel domestically and internationally.

• A valid driver's license is required.

• At least 2 years of direct site monitoring experience in the bio/pharma/CRO sector.

• A Bachelor's degree is preferred, with a strong focus on science and/or biology.

🏝️ Benefits

• Equal opportunity employment consideration without regard to legally protected status.

• Chance to contribute to therapies that benefit patients.

• Remote work arrangement.