Senior Clinical Research Associate

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

📋 Description

• Lead the qualification, feasibility, and readiness processes for designated clinical trial sites.

• Take ownership of site startup and activation tasks, which include collecting and reviewing essential regulatory and startup documents.

• Ensure that investigators, study coordinators, and site personnel are well-prepared to enroll patients in an efficient and compliant manner.

• Collaborate with the Clinical Trials Manager and study leadership on site contracting and budgeting efforts, ensuring timely activation of sites.

• Monitor startup milestones and actively identify and address activation obstacles.

• Act as the primary operational liaison for assigned clinical trial sites.

• Foster and sustain strong relationships with investigators, coordinators, and site staff.

• Propel patient screening and enrollment initiatives to meet study recruitment targets.

• Oversee site performance across assigned sites and implement strategies to enhance enrollment, protocol adherence, and study execution.

• Work in partnership with sites to tackle operational challenges and sustain study momentum.

• Conduct site initiation visits and deliver study-specific training to investigators and site personnel.

• Provide ongoing education to sites throughout the study execution phase.

• Ensure that study activities are conducted in compliance with the protocol, GCP, FDA regulations, and company policies.

• Participate in investigator meetings, study team meetings, and site training sessions.

• Execute monitoring activities as necessary to guarantee study quality, compliance, and adherence to protocols.

• Review site documentation and study records for thoroughness and precision.

• Identify protocol deviations, compliance issues, and operational risks, and escalate them as necessary.

• Ensure that site documentation is comprehensive, accurate, maintained in line with study requirements, and ready for inspection at all times.

• Collaborate closely with the Clinical Trials Manager, Sr. Clinical Program Manager, Clinical Affairs, Regulatory, Quality, and Data Management teams.

• Relay site feedback, enrollment trends, operational issues, and emerging risks to study leadership.

• Contribute to the ongoing enhancement of site activation, enrollment, and study execution processes.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a relevant scientific field.

• Over 7 years of clinical research experience in the medical device sector.

• Proven experience in managing site startup, activation, enrollment, and clinical trial execution activities.

• Experience in site qualification, initiation, monitoring, and management tasks.

• Experience with catheter-based cardiovascular medical device studies is highly preferred.

• Strong understanding of FDA regulations, ICH/GCP guidelines, and clinical research operations.

• Excellent written and verbal communication abilities.

• Strong organizational, relationship-building, and problem-solving capabilities.

• Willingness and ability to travel up to 60% for site startup, activation, training, monitoring, and execution activities.

• Thrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and teamwork are crucial for success.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and advancement.

• Flexible working hours and remote work options.

• A collaborative and innovative work environment.