Process Improvement - Clinical Research Coordinator II

For over 50 years, Charlotte Radiology has been a trusted partner and industry leader in providing expert clinical imaging services and exceptional patient care. Charlotte Radiology serves NC/SC area healthcare providers and patients through advanced imaging technology, 40 convenient locations, and 500 team members – 90% of whom directly touch patient care. Our mission and vision are to be recognized as the premier radiology expert, where people come first - solidified through collaborate teamwork and quality-driven, customer focused services.

Charlotte Radiology values each individuals’ unique perspectives. Here, you will be a valued member of a larger diverse and inclusive team of experts all invested in one common goal – delivering exceptional care to our patients.

POSITION SUMMARY: The Clinical Research Coordinator II is responsible for clinical coordination, regulatory, business, and other research-related activities and documentation for clinical trials conducted by Charlotte Radiology providers. This includes following industry standards and applicable regulations. The Clinical Research Coordinator II is responsible for communication between providers, sponsors, and outside healthcare affiliates on research related matters.

Essential Duties And Responsibilities

• Coordinate and oversee all aspects of clinical research studies form initiation to completion
• Assists with clinical, regulatory, business, and other documentation associated with radiology research projects/clinical trials
• Participates in study start-up activity including budgeting process and oversight of contract review (performed by outside counsel), works with the Research Committee, PI and others to initiate new research projects
• Perform independent and dependent work in preparation and coordination of study submission to IRB and other appropriate committees following regular deadlines
• Communicate with study staff, IRB, sponsors, study partners in a courteous and professional manner; Meet with study sponsor representatives as needed
• Maintain and organize electronic and paper regulatory documents, study files and patient binders
• Track and enter regulatory submissions using electronic databases and prepare reports within the databases
• Respond to all queries and adverse events in a timely manner in accordance with study protocols and contracted timelines
• Consent clinical trial patients, follow up with phone calls / visits and make sure all protocols are followed. Will also be responsible for screening and recruitment of clinical trial patients
• Ensure proper handling and storage of investigational products, patient information, and study binders
• Communicate for themselves and on behalf of the PI potential issues to regulatory supervisor, study team members, and investigators
• Assist investigators with data collection, entry, and analysis
• Identify appropriate medical imaging, redact information, and upload images to a central repository
• Other projects (potentially clinical data driven) as needed
  
  

Minimum Qualifications

Education/Licensing/Certification:

• Bachelor’s Degree
• Bachelor’s Degree in Health/Science preferred
• Certified Clinical Research Professional or Coordinator required, or willing obtain certification within 6 months of employment
  
  

Experience (years And Type)

• 3 years of Clinical Research experience
• Clinical Research Coordinator experience preferred
  
  

Knowledge And Skills

• Advanced computer skills including clinical trial management software
• Understanding of FDA guidelines and regulations and principles of Good Clinical Practices (GCPs)
• Ability to create and negotiate clinical trial budgets with next-level oversight and support
• Ability to work independently and multitask
• Self-starting, detail-oriented individual.
• Strong organizational and problem-solving skills
• Excellent verbal and written skills
• Ability to work effectively with patients, medical faculty, and staff
• Ability to understand and implement protocols and teach them to clinic personnel
• Ability to create and negotiate clinical trial budgets
• Expert knowledge of medical terminology and radiology imaging
• Working knowledge of EPIC
  
  

Travel Required (% of time):

• 0-25%
  
  

Physical Requirements & Work Environment

• Less than half a day of walking and standing
• Lift up to 25lbs
• Frequent travel from office to clinical setting (typically hospital) where principal investigator radiologists work
  
  

Charlotte Radiology offers competitive base salary and comprehensive health and welfare benefits including Medical, Dental, Vision, Flexible Spending Accounts, PTO, Telehealth, Disability, Employee Assistance Program, and 401k Retirement Savings.

Charlotte Radiology is an equal opportunity, at-will employer, and administers all personnel practices without regard to race, color, religion, sex, gender, age, ancestry, national origin, mental or physical disability or medical condition, sexual orientation, gender identity or expression, marital status, military or veteran status, genetic information, or any other category protected under federal, state, or local law.