Clinical Research Coordinator, Senior

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

# Clinical Research Coordinator, SeniorFairfax OfficeFull-Time / Non-ExemptClinical2901 Telestar Court Suite 200 Falls Church, VA 22042Apply Now## Job Description#### Location: Fairfax, VA#### Status: Full-Time/Non-Exempt#### **Salary Range: $37.00-$42.00**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:* No Nights, weekends, or holidays!* 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* Career Advancement Opportunities* Employee Referral Bonuses* 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