Clinical Research Coordinator

Virginia Heart; Falls Church (VA); Híbrido; USD 43.000 - 52.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Life Insurance

401K plan

Paid time off

Employee referral bonus

Profit sharing

Descripción de la vacante

Virginia Heart is seeking a Clinical Research Coordinator for our outpatient cardiology setting in Northern Virginia. The role involves planning, directing, and analyzing cardiac drug and device trials while maintaining GCP/ICH guidelines and FDA regulations.

The position requires 3+ years of clinical and coordination experience, strong organization, and proficiency with EMR systems such as EPIC, plus MS Office tools. No evenings or weekends included in schedule; comprehensive benefits offered.

Formación

• Minimum of 3 years prior clinical experience.
• Minimum of 3 years prior clinical research study coordination experience (preferably cardiology).
• Strong organizational and analytical skills.
• Knowledge of regulatory document collection and IRB interaction.
• Detail oriented with excellent written and verbal communication skills.
• Excellent time management skills, team player able to work independently.
• EMR experience, EPIC a plus; proficiency with Excel, Word and Outlook.

Responsabilidades

• Monitors study activities to ensure protocol compliance and regulatory policies.
• Assesses eligibility of potential patients via screening interviews and medical record review.
• Obtains informed consent and educates patients as required.
• Records adverse events and reports to investigators and oversight bodies.
• Prepares for quality audits by sponsors or regulators.
• Identifies protocol problems and assists in resolutions.
• Prepares study documents, budgets and progress reports.

Conocimientos

Clinical coordination

Regulatory knowledge

Time management

Time management

Herramientas

EPIC EMR

Microsoft Excel

Microsoft Word

Microsoft Outlook

Descripción del empleo

Location

Fairfax, VA

Job Status

Full-Time/Non-Exempt

Salary Range

$31.00 - $38.00

Work Hours

• No Evenings
• No Nights
• No Weekends
• No Major Holidays

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.

Benefits

• Comprehensive benefits package with low premiums (Medical, dental and vision)
• Life insurance of 50K covered by Virginia Heart, with option to purchase additional
• 401K pension plan based on profit and a percentage of salary
• Paid Short Term Disability with optional long-term insurance available for purchase
• Employee assistance program for mental and physical well-being
• Up to 28 days paid time off, with accrual of 1 additional vacation day per year through year 10
• Annual merit-based increases
• Employee Appreciation Events, includes therapy dogs, raffles, other fun rewards
• Career Advancement Opportunities
• Employee Referral Bonus
• Semi-annual employee surveys
• Employee Discount Programs
• Flexible spending accounts, pretax dollars for health and dependent care
• Employee Committee Opportunities (e.g., Diversity/ Inclusion, Employee Advisory Committee)

Position Summary

The Clinical Research Coordinator will work in office at the Loudoun Office location (upon completion of training period at the Fairfax location), planning, directing, evaluating and analyzing clinical research trials related to cardiac drug and device trials. Maintaining GCP/ICH guidelines and FDA regulations is required at all times.

Responsibilities

• Monitors study activities to ensure compliance with protocols and with relevant, federal, state regulatory and institutional policies. 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 eligibility of potential patients through methods such as screening interviews, review of 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.

Requirements

• Minimum of 3 years prior clinical experience required
• Minimum of 3 years prior clinical research study coordination (preferably cardiology) experience required
• Strong organizational and analytical skills
• Knowledge of regulatory document collection and IRB interaction
• Detail 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

This job description in no way states or implies that these are the only job duties to be performed by the employee occupying this position. Employee may be required to follow other job-related instructions and to perform other job-related duties as requested, subject to all federal, state, and municipal laws.