Clinical Research Associate II – FSP

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

📋 Description

• Serve as the primary contact and site manager for all phases of clinical research studies.

• Establish and maintain robust relationships with site personnel to ensure consistency throughout trial phases.

• Conduct clinical study site management and monitoring activities in accordance with ICH/GCP, SOPs, laws, regulations, protocols, and monitoring plans.

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

• Coordinate tasks with sponsor roles to confirm Site Readiness.

• Engage in site selection and validation processes.

• Execute both remote and on-site monitoring and oversight activities.

• Ensure site data is complete, accurate, and impartial.

• Safeguard the rights, safety, and well-being of subjects.

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

• Prepare precise visit and non-visit contact reports.

• Gather, review, and oversee regulatory documentation.

• Communicate with investigators and site staff regarding protocol implementation, recruitment, retention, deviations, audits, inspections, and site performance.

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

• Maintain information and documentation within clinical trial management and electronic trial master file systems.

• Contribute to the CRA team's knowledge as a subject matter expert, buddy, or mentor.

• Assist or lead audit and inspection activities.

• Conduct co-monitoring visits.

• 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 verbal and written).

• Solid understanding and working knowledge of clinical research, phases of clinical trials, and current GCP/ICH and country-specific clinical research laws and guidelines.

• Familiarity with Global and Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Demonstrated expertise in site management, including overseeing site performance and patient recruitment.

• Proven high-level monitoring skills with independent professional judgment.

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

• Ability to comprehend and analyze data/metrics and respond accordingly.

• Capacity to manage intricate issues in a solution-focused manner.

• Skills in root cause analysis and implementation of preventative/corrective actions.

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

• Capability to work independently across multiple protocols, sites, and therapy areas.

• Ability to prioritize tasks and handle multiple responsibilities simultaneously.

• Proficiency in working effectively within a matrix multicultural environment.

• A mindset focused on high quality and compliance.

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

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

🏝️ Benefits

• Equal opportunity employer.

• Remote work arrangement available (United States).