PRN Clinical Research Nurse

PRN Clinical Research Nurse

PRN Clinical Research Nurse
Department: Operations
Location: USA - Maryland - Baltimore
Employment Type: Part Time
Job Type: PXL Temporary


Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.

Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Description:
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).
Assumes responsibility for patient care and study conduct assignments. Ensures that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assesses compliance, symptoms, etc. per study protocol. Arranges for pre/post procedure laboratory work to be performed.
Ensures that all established timelines relating to areas of responsibility and assigned projects are met.
Assesses, monitors, records, and reports patient¿s condition and reaction to drugs and treatments to the appropriate physician. Dispenses medication as directed.
Performs or arranges for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.
Collects and prepares data. Organize and enter data into case report forms. Enter data into databases when required. Assists physicians in completing flow sheets in medical records and progress notes. Updates and maintains the contents of the Clinical Study File.
Assists project coordinators and project managers in reviewing informed consent documents, source documents, and case report forms.
Reviews consent forms, treatment schemas, and side effects of drugs with study participants and research team members. Administers Informed Consents according to Good Clinical Practice guidelines. Discusses potential adverse events and study schedules with study participants.
Acts as participant advocate in the conduct of clinical studies.
Performs daily equipment and drug checks as required by departmental policy. Documentation is completed accordingly. Reports equipment failures to the Clinical Services Leader. Arranges for replacement of expired or used supplies in conjunction with the Clinical Services Leader.
Participates and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives.
Assigns tasks and clinical procedures to appropriately trained research assistants and research technician.
Responsible for clinical trial material accountability in coordination with EPCU Pharmacy Technician and Pharmacist. Maintains security of blinded code and notifies physician of participant conditions, which may require blinded code identification.
Supports the implementation and application of ClinBase¿ in the EPCU.
Maintains and participates in the fiscal objectives of the unit and recognizes cost reduction opportunities. Participates in quality improvement initiatives.
Demonstrates Guest and Staff Relations standards in all activities.
Assumes 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
Experience:
BSN preferred or relevant work experience.
Licensed RN, BLS certification.
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.