Senior Clinical Research Coordinator - Cardiac Trials

Virginia Heart; Fairfax (VA); Sur place; USD 85 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical/Dental/Vision plans

401(k) Retirement Plan

Paid Short-Term Disability

Employee Assistance Program

Three Weeks of Paid Vacation

Paid Sick Leave

Annual Merit-Based increases

Employee Discount Programs

Quarterly Employee Appreciation Events

Résumé du poste

Virginia Heart is seeking a Senior Clinical Research Coordinator to plan, direct, evaluate and analyze cardiac drug and device trials, ensuring compliance with GCP/ICH and FDA regulations in an outpatient cardiology setting.

You will oversee study start-up, monitor enrollment, mentor staff, and serve as main sponsor contact while maintaining detailed regulatory files. Travel up to 10% is required. Competitive benefits and a collaborative team environment are provided.

Qualifications

• Minimum of 4 years of clinical research experience.
• Registered Nurse Licensure or bachelor's degree in healthcare preferred.
• CCRC or CCRP certification required or preferred.

Responsabilités

• Oversee complex studies to ensure protocol and regulatory compliance and complete regulatory files.
• Coordinate study start-up activities, including IRB submissions and site initiation visits.
• Provide leadership to junior research staff and serve as primary contact for sponsors.
• Maintain detailed study records, including CRFs, drug dispensation records, and regulatory documents.
• Monitor patient enrollment and follow-up, and document retention, dropouts, and outreach.
• Record and report adverse events in consultation with investigators and submit to oversight agencies.
• Prepare for quality audits and assist in protocol revisions.
• Travel up to 10%.

Connaissances

GCP knowledge

FDA regulations

IRB requirements

MS Office

Time management

Formation

Registered Nurse Licensure

Bachelor's degree in healthcare

Outils

EPIC EMR

Trial management systems

EDC platforms

Description du poste

Virginia Heart is seeking a Senior Clinical Research Coordinator to plan, direct, evaluate and analyze cardiac drug and device trials, ensuring compliance with GCP/ICH and FDA regulations in an outpatient cardiology setting.

You will oversee study start-up, monitor enrollment, mentor staff, and serve as main sponsor contact while maintaining detailed regulatory files. Travel up to 10% is required. Competitive benefits and a collaborative team environment are provided.