Clinical Research Coordinator

Virginia Heart; Leesburg (VA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Affordable Medical, Dental and Vision

401(k) Retirement Plan

Paid Short-Term Disability

Employee Assistance Program

Three Weeks of Paid Vacation

One week of Paid Sick Leave

Annual Merit-Based increases

Employee Discount Programs

Quarterly Employee Appreciation Events

Job summary

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

You will monitor study activities, coordinate startup, manage regulatory files, enroll patients, obtain informed consent, and support budgets and audits. This role offers competitive wages and growth within a trusted team.

Qualifications

• Biology or Health Science degree preferred.
• At least three years of experience in clinical research coordination, preferably cardiology.
• Strong knowledge of GCP, FDA regulations and IRB requirements.
• Fluent or functional Spanish preferred.
• Excellent organizational, analytical and communication skills.

Responsibilities

• Monitor study activities for protocol compliance and regulatory files.
• Coordinate study start-up activities including IRB submissions.
• Serve as primary sponsor contact and maintain study records.
• Track enrollment and document dropout information.
• Educate and obtain informed consent from patients.
• Assist in budgets and financial disbursements for studies.
• Conduct monitoring visits and address issues promptly.
• Mentor junior staff on protocol and regulatory compliance.

Skills

Spanish language (prefered)

GCP/Regulatory compliance

Regulatory coordination

Communication skills

Time management

Education

Biology or Health Science degree

Tools

EPIC

EMR

Clinical trial management systems

Excel

Word

Outlook

Job description

Are you looking for new career opportunities, great wages, excellent benefits, and work-life balance? Follow your heart to Virginia Heart!

At Virginia Heart, we are looking for a professional Clinical Research Coordinator will plan, direct, evaluate and analyze clinical research trials related to cardiac drug and device trials . Maintaining GCP/ICH guidelines and FDA regulations is always required .

When you work with Virginia Heart, you will enjoy a dedicated and experienced staff, competitive wages, excellent benefits and the following rewards and incentives:

• Affordable Medical, Dental and Vision plans
• 401(k) Retirement Plan
• Paid Short-Term Disability
• Employee Assistance Program for Mental and Physical well-being
• Three Weeks of Paid Vacation upon eligibility
• One week of Paid Sick Leave
• Annual Merit-Based increases
• Employee Discount Programs
• Quarterly Employee Appreciation Events to include therapy dogs, raffles, and other fun events.

Virginia Heart is Northern Virginia's premier cardiovascular practice, bringing an unparalleled standard of excellence to our patients. We are seeking experienced professionals to join our team in our outpatient cardiology setting. Every employee, at every level, begins their journey at Virginia Heart learning about the history of the organization and its established culture built on trust and integrity. Our employees drive this culture, and we want you to be a part of it.

Roles and Responsibilities:

• Monitors study activities to ensure compliance with protocols and with relevantfederal, state regulatory and institutional polices. Ensure that all regulatory files are complete, accurate, and up to date.
• Coordinate study start-up activities, including IRB submission, site initiation visits, and pre-study visits.
• Serves as the primary point of contact for sponsors.
• Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Tracks enrollment status of patients and documents dropout information such as dropout causes and patient contact efforts.
• Assesses potential patients' eligibility through methods like screening interviews, reviewing medical records, and discussions with physicians and assistant physician providers.
• Responsible for education and appropriate documentation of patient informed consent.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Participates in preparation and management of research budgets and monetary disbursements.
• Conducting monitoring visits and resolves issues as needed in a timely manner.
• Mentor and train junior research staff and new team members on study protocol, procedures and regulatory compliance.
• 10% Travel Required

Skill Requirements and Qualifications:

• Biology or Health Science degree, preferred
• Fluency in Spanish preferred
• At least three years of experience in clinical research coordination, preferably cardiology
• Clinical experience preferred
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred
• Strong organizational and analytical skills required
• In depth knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB requirements
• Proficiency and clinical trial management systems and electronic data capture platforms
• Flexibility with working hours to accommodate study needs
• Detailed oriented, excellent written and verbal communication skills
• Excellent time management skills, team player with the ability to work independently
• EMR experience, (EPIC a plus) and Microsoft Excel, Word and Outlook