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Job Discription
Key Accountabilities
*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.
*Maintain IP chain of custody in coordination with the Pharmacy.
*Administer concomitant medication, 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 situations.
*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.
Education
*Valid State LVN
*Current Advanced Cardiac Life Support (ACLS) required. (within 6 months of hire)
*Current Basic Life Support (BLS) required.
Language Skills
*Fluent in English
*Bilingual preferred
Minimum Work Experience
*Preferably 1 year of clinical experience in an acute hospital setting or comparable experience in a clinical research environmentEEO 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.
