Clinical Research Associate II

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

📋 Description

• Serve as the main point of contact and site manager throughout all stages of a clinical research study.

• Assume overall accountability for assigned sites.

• Build robust relationships with sites and ensure continuity across all trial phases.

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

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

• Coordinate and oversee tasks with sponsor roles to ensure site readiness.

• Engage in site selection and validation processes.

• Execute remote and on-site monitoring and oversight tasks.

• Ensure that site data is complete, accurate, and unbiased while safeguarding subjects’ rights, safety, and well-being.

• Carry out validation, initiation, monitoring, and closeout visits; produce precise visit and non-visit contact reports.

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

• Communicate effectively with investigators and site personnel regarding protocol implementation, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance.

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

• Manage information and documentation within CTMS, eTMF, and other systems.

• Contribute to CRA team expertise as a process subject matter expert, mentor, and best-practice advocate.

• Assist or lead auditing and inspection activities.

• Conduct co-monitoring visits as necessary.

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

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

⛳️ Requirements

• Proficient in local languages and English (both verbal and written).

• Strong understanding and practical knowledge of clinical research, clinical trial phases, current GCP/ICH, and national clinical research laws and guidelines.

• Solid understanding of Global, Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

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

• Proven high level of monitoring skill with independent professional judgment.

• Strong IT competency, including MS Office and clinical IT applications.

• Ability to comprehend and analyze data/metrics.

• Capacity to manage complex issues and perform root cause analysis with preventive and corrective actions.

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

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

• Ability to function effectively in a matrix multicultural environment.

• Willingness to travel domestically and internationally approximately 65%-75% of working time; anticipated travel is approximately 2-3 days per week.

• Valid driver's license is required.

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

• Bachelor’s degree with a strong focus on science and/or biology.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement.

• Equal opportunity employment.