Clinical Research Coordinator - Virginia Heart

Location:  Fairfax, VA

Status:  Full-Time/Non-Exempt

Salary Range:  $30.00 - $35.00

• 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. 

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 Fairfax Office 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 institutional policies. Ensure that all regulaory files are complete, accurate, and up to date.
• Coordinate study start-up activites, 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' eligibilty through methods like screening interviews, reviewing medical records, and discussionswith 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 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 monitoriing 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

REQUIREMENTS:

• Minimum of 3 years prior clinical experience required
• Minimum of 3 years prior clinical research study coordination (preferably cardiology) experience required
• Biology or Health Science degree, preferred
• Fluency in Spanish, preffered
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP), preferred
• Strong organizational and analytical skills
• In depth Knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB requirements
• 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
• Proficiency and clincal trial management systems and electronic data capture platforms
• Flexibility with working hours to accommodate study needs.

   

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.