Asheville North Caroline
Pay From: $35 Per Hour
MUST:
Licensed as a Registered Nurse in the state of North Carolina
2+ Years of experience as a Registered Nurse and Clinical Research experience
Experience in the oncology field a huge plus
Maintaining of study-related materials, investigational products and specimens
Collecting, recording and reporting accurate data and demonstrate per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
Strong understanding of protocol requirements as well as the ability to execute study procedures
Experience with IRB/IEC review as well as associated documents Maintain site credentials and ensures updated GCP, licenses remain on file
Collecting, recording and reporting accurate data per FDA guidelines, and review for accuracy
Ensuring integrity of data of patients enrolled in clinical trials
Managing monitoring visits and ensure proper preparations, support, documentation and follow up
Developing study budgets
Understanding of payment terms of study budgets and items that need to be invoiced for clinical studies
Associates in Nursing or Bachelor’s in Nursing
DUTIES:
The Duties of the Registered Nurse include but are not limited to the following:
Provide support with the phases 1-3 clinical research studies
Coordinate care of patient on clinical reseearch protocols in accordance with GCP, ICH and FDA guidelines
Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires
Assess patients on the basis of detailed criteria
Review informed consent forms and have discussion in compliance with SOP’s
Review and interpret diagnostic test results and required documentation as per protocol
Assess and determine relationship of adverse events to the investigational drugs
Report and follow up on adverse events
Dispense study medications following protocol requirements
Maintain site credentials and ensures updated GCP, licenses remain on file
Ensure scientific integrity of data of patients enrolled in clinical trials
Communicating and working with study monitor
Escalate non-compliance of protocols to investigators nd leadership
Develop study budgets
Quadrant is an affirmative action/equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, status as a protected veteran, or status as an individual with a disability. “Healthcare benefits are offered to all eligible employees according to compliance mandated by the Affordable Care Act“.
