Clinical Research Coordinator, Senior

Virginia Heart; Fairfax (VA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

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

Job summary

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.

Responsibilities

• 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%.

Skills

GCP knowledge

FDA regulations

IRB requirements

MS Office

Time management

Education

Registered Nurse Licensure

Bachelor's degree in healthcare

Tools

EPIC EMR

Trial management systems

EDC platforms

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 Senior 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:

• Oversee Complex studies to ensure compliance with protocols and with relevant federal, state regulations, and institutional policies. 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.
• Provide leadership and guidance to junior research staff.
• Serve as the primary point of contact for sponsors.
• Maintain detailed study records, including case report forms, drug dispensation records, and regulatory documents.
• Monitor patient enrollment, track retention and dropout information, and document follow-up and outreach efforts.
• Assess potential patients' eligibility by reviewing medical records, conducting interviews, and collaborating with providers.
• Responsible for education and appropriate documentation of patient-informed consent.
• Record and report adverse events and side effects in consultation with investigators, ensuring timely submission to oversight agencies.
• Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identify protocol deviations and assist in problem resolution efforts, such as protocol revisions.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Participate in preparation and management of research budgets and monetary disbursements.
• Conduct monitoring visits and resolve 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:

• Minimum of 4 years of clinical research experience.
• Registered Nurse Licensure, or bachelor's degree in healthcare or related field strongly preferred
• Must hold one of the following credentials: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP)
• 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 accomadate study needs.
• Detail-oriented, excellent written and verbal communication skills.
• Excellenttime management skills and ability to work independently.
• EMR experience, (EPIC a plus) and Microsoft Excel, Word and Outlook