Clinical Research Nurse

Department: Operations

Employment Type: Full Time

Location: Vertex Clinical Research | Clermont FL

Reporting To: Austin Wing

Description

Essential Job Duties:

• Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: 
  • Screening of patients for study enrollment; 
  • Patient consents; 
  • Patient follow-up visits; 
  • Documenting in source clinic charts; 
  • Entering data in EDC and answers queries; 
  • Obtaining vital signs and ECGs; 
  • May perform basic lab procedures per protocol, such as:  blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; 
  • Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc. 
  • Requesting and tracking medical record requests; 
  • Updating and maintaining logs, chart filings; 
  • Maintaining & ordering study specific supplies; 
  • Scheduling subjects for study visits and conducts appointment reminders; 
  • Building/updating source as needed; 
  • Conducting monitoring visits and resolves issues as needed in a timely manner; 
  • Ensuring study related reports and patient results are reviewed by investigator in a timely manner; 

• Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;
• Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• May set up, train and maintain all technology needed for studies.
• May assist with study recruitment, patient enrollment, and tracking as needed;
• Maintaining confidentiality of patients, customers and company information, and;
• Performing all other duties as requested or assigned. 

Skills, Knowledge and Expertise

• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40 wpm);
• Proficiency with performing clinical procedures such as injections, vitals, EKGs, phlebotomy, infusions, etc. is required.  
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills. 
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
• Must be professional, respectful of others, self-motivated, and have a strong work ethic.
• Must possess a high degree of integrity and dependability.
• Ability to work under minimal supervision, identify problems and implement solutions.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

Benefits

• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. 
• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.