• Clinical Research Nurse Practitioner/Physician Assistant

    Posted Date 3 weeks ago(9/25/2018 4:46 PM)
    Job ID
    2018-3203
    # of Openings
    1
    Job Location(s)
    US-MD-Bethesda
    Category
    Research
  • Overview

    Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

     

    We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

     

    Duties & Responsibilities

    Medical Science & Computing is searching for a Clinical Research Nurse Practitioner or Physician Assistant to support the National Institutes of Health (NIH) in the development of malaria vaccines.  This opportunity is a permanent, full-time position on-site at the NIH in Bethesda/Rockville, MD.

     

    The primary function of this position is to coordinate and assist the clinical team in implementing U.S. and international clinical trial vaccine programs, ensuring that studies are carried out according to protocol, standard operating procedures, and applicable guidelines and regulations. International collaborations and clinical sites are active in several centers across Africa.

     

    ESSENTIAL POSITION FUNCTIONS

     

    Serves as clinical representative in managing protocol execution, with oversight

    At the NIH: 

    • Explains research study to participants, including purpose, duration, risks and benefits prior to any study procedures at screening
    • Performs clinical study procedures per protocol as required throughout the trial, including physical exams, vital signs, phlebotomy, and electrocardiograms (ECG’s)
    • Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits.
    • Consents subjects, review medical/surgical history, provide medical assessment & care, perform protocol procedures, prescribe and dispense medications, evaluate and report laboratory findings & adverse events to the Principal Investigator
    • Documents adverse events and update source documents based on subject history
    • Completes case report forms (CRFs) and assist in data query resolution

    For international and NIH studies: 

    • Interacts across teams for study design and execution
    • Maintains full knowledge of study documents. 
    • Assists with drafting of study materials
    • Prepares for and coordinates site visits made by sponsors or study monitors during the course of and at the close of the study
    • Develops and uses CRFs
    • Supervises data collection and management including source documents
    • Coordinates the collection, processing, shipment and storage of bio-specimens
    • Manages close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations
    • Assists in developing study budgets, and track budget expenses and billing
    • Creates monthly and annual reports for open studies as required
    • Attends required meetings
    • Performs other duties as assigned

     

     

    Requirements

    • MS Degree with 3+ years’ experience in addition to Current Licensure and/or Certification to practice as a Nurse Practitioner or Physician Assistant in the state of Maryland
    • Minimum 3 years of clinical trial experience, Phase I trials a plus
    • Clinical Research Coordinator experience preferred
    • Basic Life Support (BLS) training required, Advanced Cardiac Life Support (ACLS) training preferred
    • Knowledge of Good Clinical Practices (GCP) and Health Insurance Portability and Accountability Act (HIPPA) guidelines
    • Experience with Malaria research is a plus
    • Phlebotomy experience is preferred
    • Excellent interpersonal and communication skills
    • High attention to detail
    • International travel will be required
    • Evening and weekend work may be required
    • Interest in global health and/or vaccine research
    • Ability and willingness to work with a diverse population.

     

    Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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