Senior Clinical Research Associate

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 responsibility for designated sites.

• Build strong relationships with sites and ensure consistent engagement throughout all phases of the trial.

• Execute clinical study site management and monitoring tasks in accordance with ICH-GCP, sponsor SOPs, local laws and regulations, the study protocol, site monitoring plan, and related documents.

• Acquire a comprehensive understanding of the study protocol and associated procedures.

• Coordinate and manage tasks with sponsor roles to ensure Site Readiness.

• Engage in activities related to site selection and validation.

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

• Carry out validation, initiation, monitoring, and close-out visits.

• Produce timely, clear, comprehensive, and accurate reports for visits and non-visit communications.

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

• Liaise with investigators and site personnel regarding protocol execution, recruitment, retention, deviations, regulatory paperwork, audits/inspections, and site performance.

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

• Collaborate with internal teams, vendors, IRBs/IECs, and regulatory bodies.

• Maintain records and documentation in CTMS, eTMF, and other systems.

• Act as a subject matter expert on processes, sharing best practices and providing training.

• Support or lead audit and inspection activities.

• Mentor or partner with junior CRAs and conduct co-monitoring visits.

• Contribute to business initiatives and projects.

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

⛳️ Requirements

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

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

• Practical knowledge of Good Documentation Practices.

• Solid understanding of global and country/regional clinical research guidelines.

• Proven ability to mentor and lead others.

• Established site management skills, including independent oversight of site performance and patient recruitment.

• Demonstrated advanced monitoring skills with independent professional judgment.

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

• Ability to interpret and analyze data and metrics.

• Experience in conducting site motivational visits to enhance site enrollment.

• Competence in managing complex issues while maintaining a solution-oriented approach.

• Ability to perform root cause analysis and implement preventive and corrective measures.

• Capability to mentor junior CRAs and conduct co-monitoring visits.

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

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

• Capacity to prioritize and manage multiple tasks in a dynamic environment.

• Ability to work effectively within a matrix multicultural setting.

• Commitment to customer focus and adherence to quality and compliance standards.

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

• A current driver's license is required.

• A minimum of 4 years of direct site management (monitoring) experience in the bio/pharma/CRO industry.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Flexible work arrangements and work-life balance initiatives.