Inclusive of, but not limited to the following:
Provides clinical nursing and operations oversight as Charge Nurse, as appropriate. Charge nurse
duties are assigned on a rotating basis.
Responsible for patient and healthy study participant care and study conduct assignments.
Responsible for upholding the protocol, SOPs and GCP in all work processes to ensure efficient
and compliant clinical operation within the Early Phase Clinical Unit (EPCU), including but not
limited to daily crash and medication cart checks; recording, monitoring and following up with PI daily on Adverse Events (AE’s); and review, monitoring and following up on concomitant medications, discussing with PI as required.
Responsible for providing clinical/protocol related training to ensure understanding across the
clinic floor, guiding and directing staff and others to ensure safety and protocol compliance.
Responsible for ensuring study participant safety, identifying and responding to changes in the
study participant’s physical, mental, and/or behavior to take appropriate action, and if necessary,
notify physician and/or research team, documenting as required.
Responsible for assessment, monitoring, recording, and reporting patient’s condition and reaction to
drugs and treatments to the appropriate physician and CRC, and dispensing medication as directed.
Act as dosing nurse for studies and administer IP via any route as per protocol, nurse practice,
clarifications and guidelines. Proactively plan and prepare dosing procedures/instructions (for
example, preparing the Dosing Information Sheet).
Maintain IP chain of custody in coordination with the Pharmacy.
Administer concomitant medication (all routes), give treatments and perform other medical
procedures as prescribed by the physician (medical group).
Assist physician or perform more complex clinical procedures as required.
Respond, lead and assist in emergency and code situations by following standard emergency
protocols and SOPs.
Ensure that all nursing and protocol-related procedures are completed and documented according to
GCP and standard nursing practice.
Obtain and/or support informed consent from trial participants according to GCP guidelines and
SOP’s, as required.
Maintain and update professional competencies, ensuring knowledge and understanding of Clinical
Operating Guidelines and related hospital policies, as applicable.
Amenable to flexible working schedule as required by business and workflow, including shift
rotations, weekend and evening work, on-call obligations, as well as an understanding that flexibility
in work schedule is important to meet business needs.QualificationsSkills
Demonstrated leadership ability and critical thinking.
Proven emergency care and comprehensive assessment skills.
Ability to assess, monitor and respond to emergency situation.
Possess knowledge and skills necessary to provide care appropriate to the age and/or indication
of the study participants served.
Have the ability to manage multiple and varied tasks with enthusiasm and prioritize workload
with attention to detail.
Excellent interpersonal, verbal and written communication skills.
Demonstrated competency in all research-related tasks.
BSN preferred or relevant work experience.
Current Advanced Cardiac Life Support (ACLS) required. (within 6 months of hire)
Current Basic Life Support (BLS) required.
Fluent in English
Minimum Work Experience
Preferably 1 year of clinical experience in an acute hospital setting or comparable experience in
a clinical research environment.EEO DisclaimerPAREXEL 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.