QUALIFICATIONS

• At least 2 years working in a hospital or clinical setting
• BSN preferred or relevant work experience.
• Active Registered Nurse License in the state of Maryland
• Current Basic Life Support (BLS) certification.
• ACLS certification required within 6 months of start date

ABOUT THIS ROLE

Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans.
At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Then monitor the volunteer participants health status around the clock as per the trial protocol to ensure their safety and wellbeing.

WHAT YOU’LL DO AFTER TRAINING IS COMPLETED (INCLUDING BUT NOT LIMITED):

• Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU).
• Assume responsibility for patient care and study conduct assignments.
• Ensure that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assess compliance, symptoms, etc. per study protocol. Arrange for pre/post procedure laboratory work to be performed.
• Ensure that all established timelines relating to areas of responsibility and assigned projects are met.
• Participate and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives.
• Assess, monitor, record, and report patient’s condition and reaction to drugs and treatments to the appropriate physician.
• Collect and prepare data. Organize and enter data into case report forms.
• Enter data into databases when required. Assist physicians in completing flow sheets in medical records and progress notes. Update and maintain the contents of the Clinical Study File.
• Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.
• Act as participant advocate in the conduct of clinical studies.