Nurse Practitioner (NP) - Clinical Research

Parexel•Baltimore, MD

2d•$120,000 - $135,000•Onsite

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 Nurse Practitioner (NP) functions under the direction and guidance of a licensed physician to ensure the safety of study participants. The NP is responsible for reviewing medical history and physical assessment of potential study participants for the purpose of qualifying participants for studies. The NP diagnoses healthcare problems, develops, and implements treatment plans under the direction of a physician. Your time here: As a Nurse Practitioner , you take the lead on study participant safety and are involved in all aspects of the trial development process at the Unit. You work as part of a team and will collaborate with other departments such as Nursing, Pharmacy, Screening, Laboratory, Clinical, Recruitment, and Project Management. Your work environment is fast-paced, interesting, dynamic, and rewarding.

Requirements

At least 2 to 3 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

Responsibilities

Execute all appropriate Sub-Investigator responsibilities on assigned projects.
Provide Information and obtain informed consent from potential research subjects.
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.
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.
Assists with training of clinical operations personnel.
Liaises with sponsors on study conduct and study progression when required.
Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents when required.
Establishes working relationships with client representatives, promoting confidence and reliability regarding the CPRUs operations.
Ensures that the quality standard of clinical work product is met.
Assumes other duties and responsibilities as assigned.

Benefits

For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.

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