Senior Clinical Research Coordinator (Cardiac Trials Lead)

Virginia Heart; Falls Church (VA); Hybrid; USD 51,000 - 58,000; Full time

Benefits offered by this job

No Nights, weekends, or holidays

Affordable Medical, Dental and Vision

401(k) Retirement Plan

Paid Short-Term Disability

Three Weeks Paid Vacation

Paid Sick Leave

Merit-Based increases

Career Advancement Opportunities

Employee Referral Bonuses

Employee Discount Programs

Job summary

Virginia Heart is seeking a Senior Clinical Research Coordinator for our Fairfax office to plan, direct, and analyze cardiac drug and device trials. You will ensure GCP/ICH compliance, regulatory filing accuracy, and regulatory adherence while coordinating start-up activities and sponsor communications.

The role requires leadership of junior staff, robust clinical research experience, and the ability to manage budgets and documentation.

Qualifications

• Minimum of 4 years of clinical research experience.
• Strong organizational and analytical skills required.
• In-depth knowledge of GCP, FDA regulations, and IRB requirements.
• Proficiency with EMR/EDC platforms and trial management systems.
• Detail-oriented with excellent written and verbal communication.

Responsibilities

• Oversee complex studies to ensure protocol compliance and regulatory adherence.
• Coordinate study start-up activities including IRB submissions and site initiation visits.
• Provide leadership and guidance to junior research staff.
• Serve as primary point of contact for sponsors.
• Maintain detailed study records and regulatory documents.
• Monitor patient enrollment, retention, and follow-up efforts.
• Obtain informed consent and ensure proper education/documentation.
• Record and report adverse events in coordination with investigators.
• Prepare for QA audits and manage protocol deviations.
• Assist in study budgeting and budget disbursements.
• Conduct monitoring visits and mentor new staff.
• Travel up to 10% as required.

Skills

Clinical research experience

Organizational skills

Analytical skills

GCP/FDA knowledge

EMR/EDC proficiency

Education

Bachelor's degree in healthcare or related field

RN licensure preferred

Tools

EPIC

Clinical trial management systems

Microsoft Excel

Outlook/Word

Job description

Virginia Heart is seeking a Senior Clinical Research Coordinator for our Fairfax office to plan, direct, and analyze cardiac drug and device trials. You will ensure GCP/ICH compliance, regulatory filing accuracy, and regulatory adherence while coordinating start-up activities and sponsor communications.

The role requires leadership of junior staff, robust clinical research experience, and the ability to manage budgets and documentation.