• Clinical Trials Senior Specialist

    Posted Date 2 months ago(8/21/2018 3:29 PM)
    Job ID
    2018-3133
    # 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 highly motivated Clinical Trials Senior Specialist to support the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and is on-site in Bethesda, MD.


    Major Duties and Responsibilities:

     

    • Assist the Principal Investigator in developing clinical protocols including the evaluation of feasibility and budget.
    • Successful candidate will be responsible for a large regulatory component of natural history and interventional clinical studies, which includes but is not limited to manuscript management, protocol management, safety monitoring reports management as well as adverse events reporting and the documentation related to consent visits.
    • Conduct Safety Monitoring visits, remain updated on adverse events reporting and amend the protocol as needed.
    • Manage clinical protocols by assembling and training the study team; overseeing compliance to protocol; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, DSMB, and/or other regulatory documents and research correspondence.
    • Develop study budgets, and track budget expenses and billing for relevant services.
    • 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.
    • Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study.
    • Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues.
    • Supervise, mentor and train new or junior research staff.
    • Develop and maintain study subject databases; supervise data collection and management including the collection of source documents, using and developing case report forms (CRFs), and ensuring that they are complete and accurate.
    • Execute sample collection and initial processing.
    • Supervise and coordinate the collection, processing, shipment and storage of biospecimens.
    • Manage 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.

    Requirements

    Position Requirements:

     

    • Bachelor’s degree required, Master’s degree preferred in Health Science (MHS) or Medical Science (MMSc) with a minimum of two (2) years of experience in Healthcare, Biomedical or Clinical Research, or Public Health, with a focus in clinical study coordination.
    • Nurse Practitioners and Physician Assistants with applicable experience and current Licensure and/or Certification to practice as a Licensed NP or PA in the state of Maryland are also welcome to apply.
    • NIH experience desirable but not an absolute requirement.
    • Experience using NIH clinical systems desirable but not an absolute requirement.
    • Skilled in successful patient recruitment for various clinical studies and trials.
    • Excellent interpersonal skills.
    • Organized and detail oriented.
    • Research/clinical background a must.

     

    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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