Clinical Research Study Manager Jobs in Reston, VA

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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. 

We offer great 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)
• No nights, no weekends, no holidays and no on-calls!
• Set shifts and schedules 

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 cllinical 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 instutional 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
• Detailed oriented, excellent written and verbal communications 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.