Our aim is to find a responsible nurse who can communicate well with people and doctors and will be available for the safety of our volunteers and the unit as a whole.

Responsibilities:

• Execute and coordinate a variety of specialized clinical research activities ensuring that established protocols are implemented and followed.
• Monitor patient and participant status and safety.
• Collect and organize research data.
• Educate patients and family members, for patient studies, and healthy participants about treatments and possible side effects and complications.
• Support Standard Operating Procedures (SOPs), Good Clinical Practices, 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 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.
• Contribute to the development and implementation of study/research objectives.
• Demonstrate Guest and Staff Relations standards in all activities.
• Assess, monitor, record, and report patient’s condition and reaction to drugs and treatments to the appropriate physician.
• Dispense medication as directed.
• 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 follow GCP quality study documentation.
• Act as participant advocate in the conduct of clinical studies.
• Perform equipment and drug checks as required by departmental policy.
• Report equipment failures to the Clinical Services Leader.
• Arrange for replacement of expired or used supplies in conjunction with the Clinical Services Leader.
• Support the implementation and application of ClinBase™ in the EPCU.
• Participate in quality improvement initiatives.
• Assist project coordinators and project managers in reviewing informed consent documents, source documents, and case report forms.
• Review consent forms, treatment schemas, and side effects of drugs with study participants and research team members.
• Administer Informed Consents according to Good Clinical Practice guidelines.
• Discuss potential adverse events and study schedules with study participants.
• Assign tasks and clinical procedures to appropriately trained research assistants and research technicians.
• Responsible for clinical trial material accountability in coordination with EPCU Pharmacy Technician and Pharmacist.
• Maintain security of blinded code and notifies physician of participant conditions, which may require blinded code identification.
• Assume other duties and responsibilities as assigned.
• The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all-inclusive.

Qualifications

• Excellent organizational and communication skills.
• Attention to detail is critical.
• Must be self-directed and often work with minimal supervision.
• Invasive pressure monitoring, emergency care and comprehensive assessment skills are also highly desirable.
• Computer skills and familiarity with research process is highly desirable.
• Physical Requirements: Moving and lifting patient, pushing stretchers, moving heavy monitors, visual and auditory acuity, manual dexterity, exposure to body fluids.
• BSN or relevant work experience such as MedSurg, ICU, Step-down nurses, school nurses and stay-at-home nurse experience preferred.
• Licensed RN, BLS certification.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.