Senior Clinical Research Associate – Cardiovascular Medical Device

This is a fully remote position, open to applicants in New York.

📋 Description

• Oversee site qualification, feasibility assessments, readiness, clinical study initiation, and site activation processes.

• Gather and evaluate essential regulatory and startup documentation.

• Prepare investigators, study coordinators, and site personnel for compliant patient enrollment.

• Collaborate on site contracting and budgeting to ensure prompt site activation.

• Monitor startup milestones and address any activation obstacles.

• Act as the main operational liaison for designated cardiovascular clinical trial sites.

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

• Propel patient screening and enrollment to meet recruitment targets.

• Take ownership of site performance and enhance enrollment, protocol compliance, and study execution.

• Tackle operational challenges and sustain study progression.

• Conduct Site Initiation Visits and deliver study-specific training.

• Provide continuous education for sites.

• Ensure compliance with study protocols, Good Clinical Practice (GCP), FDA medical device regulations, and company policies.

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

• Carry out clinical trial monitoring activities.

• Assess site documentation and study records for completeness and accuracy.

• Identify and report protocol deviations, compliance issues, and operational risks.

• Maintain inspection-ready site documentation.

• Collaborate with Clinical Operations, Clinical Affairs, Regulatory, and Quality teams.

• Relay site feedback, enrollment patterns, challenges, and risks to study leadership.

• Contribute to improvements in site activation, enrollment, and study execution processes.

⛳️ Requirements

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

• Over 7 years of clinical research experience supporting medical device clinical trials.

• Required experience on the sponsor side of medical device clinical research.

• Previous clinical operations experience in an early-stage medical device company is essential.

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

• Familiarity with site qualification, Site Initiation Visits (SIVs), clinical trial monitoring, and site management.

• Cardiovascular medical device clinical trial experience is highly valued, especially with catheter-based or other interventional cardiovascular technologies.

• Knowledge of Good Clinical Practice (GCP), FDA medical device regulations, and clinical research operations.

• Excellent written and verbal communication skills.

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

• Willingness and ability to travel up to 60% of the time.

• Adaptability, initiative, and teamwork in a dynamic, fast-paced early-stage medical device setting.

• Permanent authorization to work in the United States without current or future visa sponsorship is required.

• Reside in the Eastern or Central time zone and be located within reasonable distance from a major airport.

🏝️ Benefits

• Bonus opportunities.

• Equity options.

• Company-sponsored benefits.

• Opportunity to assist in delivering a pioneering therapy to patients with coronary microvascular dysfunction.

• Collaborate with an experienced leadership team.

• Make a visible impact in a collaborative, fast-paced environment.