Parexel Early Phase Clinical Unitsupports 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 Nurse Practitioner (NP)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.

What you'll do once training is complete(including but not limited):

• 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. 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

• At least 2 years of experience working as a licensed Nurse Practitioner (preferrable in a hospital setting)
• Active Nurse Practitioner License in the state of Maryland
• Analytical skills to collect information from diverse source
• Excellent organizational and communication skills

Hours/Shifts

• Primarily weekdays Monday - Friday 7:00/8:00am to 3:00pm/4:00pm
• Weekend rotation every 3rd - 4th weekend (will have a day off during the week)

Parexel is dedicated to supporting, developing and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers at Parexel.