Senior Clinical Research Coordinator Cardiac Trials Lead

Virginia Heart; Leesburg (VA); Presencial; USD 85.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision plans

401(k) plan

Short-term disability

Employee assistance program

Paid vacation

Paid sick leave

merit-based raises

Employee discounts

Team events

Descripción de la vacante

Virginia Heart is seeking a Senior Clinical Research Coordinator to plan, direct, and analyze cardiac clinical trials in an outpatient setting. You will oversee regulatory compliance, startup activities, and sponsor communications while mentoring junior staff and ensuring accurate documentation.

Requirements include 4+ years in clinical research, RN licensure or healthcare degree, and CCR/CCRP credentials or equivalent. Travel up to 10% may be required as part of study activities.

Formación

• Minimum of 4 years of clinical research experience.
• RN licensure or bachelor’s degree in healthcare strongly preferred.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) required or preferred.
• Strong knowledge of GCP, FDA regulations, and IRB requirements.
• Proficiency with trial management systems and electronic data capture platforms.

Responsabilidades

• Oversee complex studies to ensure regulatory compliance and up-to-date files.
• Coordinate study startup activities including IRB submission and site initiation visits.
• Provide leadership and guidance to junior research staff.
• Serve as primary sponsor contact and manage study records and regulatory documents.
• Monitor patient enrollment, retention, and outcome documentation.
• Assess eligibility by reviewing medical records and collaborating with providers.
• Ensure proper informed consent documentation and education.
• Record and report adverse events in coordination with investigators.
• Prepare for quality audits and implement protocol revisions as needed.
• Assist in budget management and financial disbursements.
• Perform monitoring visits and address issues in a timely manner.
• Mentor new team members on protocol and regulatory compliance.

Conocimientos

Regulatory compliance

Study coordination

IRB submissions

Sponsor liaison

Data management

Patient enrollment

Informed consent

Adverse events reporting

Trial budgeting

Mentoring staff

Travel readiness

EMR/EHR experience

Educación

RN licensure

Bachelor’s degree in healthcare

CCR/CCRP certification

Herramientas

EPIC

Descripción del empleo

Virginia Heart is seeking a Senior Clinical Research Coordinator to plan, direct, and analyze cardiac clinical trials in an outpatient setting. You will oversee regulatory compliance, startup activities, and sponsor communications while mentoring junior staff and ensuring accurate documentation.

Requirements include 4+ years in clinical research, RN licensure or healthcare degree, and CCR/CCRP credentials or equivalent. Travel up to 10% may be required as part of study activities.