Assists the CRN with conducting clinical research trials in accordance with trial protocols, state and federal regulations, and ICH/GCP guidelines by actively screening, assessing eligibility, and registering subjects for screening visits; escorting subjects through study visits; performing clinical tasks within scope of practice, and collecting associated data; and communicating information/results to the CRN and/or investigator(s).
Delivers safe care and demonstrates regard for the dignity and respect of all participants. Maintains adequate skills in clinical competencies including phlebotomy and IV insertion. Practices the principles of Universal Precautions. Understands and abides by HIPAA regulations.
Assists the CRN in maintaining neat, organized, accurate, and up-to-date source document records for all participants. Completes Case Report Forms (CRF’s) or subject tracking tools in a timely manner. Ensures that all data collection and submissions meet protocol specifications and requirements.
Communicates appropriately and effectively with TRI investigators, scientists, ARNP’s, CRN’s, and staff as well as research subjects. Serves as a subject advocate by reporting any participant needs, concerns, abnormalities, or adverse events to the Investigator or CRN with detailed and accurate information.
Maintains a clean, prepared clinical space. Performs set-up and turnover procedures in all clinical areas, per TRI SOP’s, in a timely manner.
What Will You Need:
EDUCATION AND EXPERIENCE REQUIRED:
Graduate of a nursing program
One year of clinical or research experience
Education and Experience Preferred:
Experience in the clinical/translational research environment
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
Current valid State of Florida or multi state license as a Registered Nurse
Current valid State of Florida or multistate license as a Licensed Practical Nurse
IV Certification, if LPN
Current Basic Life Support (BLS) certification
Licensure, certification or registration preferred:
Current Advanced Cardiac Life Support (ACLS) certification
The Clinical Research Assistant (CRA) - Nurse assists the clinical research nurses (CRNâ™s) and other study team members in the conduct of Phase I-IV industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines. The CRA â“ Nurse works with the CRN and other study team members to meet study-specific goals and timelines and communicates appropriately and effectively with subjects, investigators, CRNâ™s and other TRI staff. In addition, assists with phlebotomy and IV duties. The CRA â“ Nurse actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
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