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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 (located in the MedStar Harbor hospital) our highly trained and skilled Physician Assistants (PA) functions under the direction and guidance of a licensed physician to ensure the safety of study participants. The PA is responsible for reviewing medical history and physical assessment of potential study participants for the purpose of qualifying participants for studies. The PA diagnoses healthcare problems, develops, and implements treatment plans under the direction of a physician.
Job Responsibility
Execute all appropriate Sub-Investigator responsibilities on assigned projects
Executes and coordinates a variety of specialized clinical research activities ensuring compliance with GCP
Assists with the medical and clinical oversight of all aspects of clinical work performed within the CPRU
Works directly with clinical operations personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluations of inclusion/exclusion criteria for study participants
Participates in the recording and review of adverse events and concomitant medications for accuracy and consistency when required
Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies
Ensures that all established timelines relating to areas of responsibility and assigned projects are met
Supports Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation
Liaises with sponsors on study conduct and study progression when required
Liaises with physician staff of MedStar Health and local/regional medical consultants as necessary
Ensures that the quality standard of clinical work product is met
Assumes other duties and responsibilities as assigned
Requirements
At least 1 year of experience working as a licensed Physician Assistant (preferrable in a hospital setting)
Active Physician Assistant License in the state of Maryland
Analytical skills to collect information from diverse source