• Clinical Trial Study Coordinator

    Job Locations US-MD-Silver Spring
    # of Openings
    1
    Category
    Medical Research
    Type
    Regular Full-Time
  • Overview

    CAMRIS International is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

     

    CAMRIS is seeking a Clinical Trial Study Coordinator who will be responsible for clinical trial support services at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

     

    *This is a forecasted position and it is contingent upon contract award. 

    Responsibilities

    • As a Study Coordinator you would be expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. 
    • Responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Manage
    • Administratively and clinically manage an average of six to eight clinical trials
    • Adhere to Research SOP’s
    • Adhere to Good Clinical Practices and the study protocols
    • Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
    • Discuss study protocols with patients and verify the informed consent documentation
    • Provide patient with written communication of their participation (i.e. copy of the signed informed consent)
    • Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient
    • Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study
    • Dispense study medication in a professional and accountable manner following protocol requirements
    • Collect, process, and ship blood/urine specimens at scheduled patient visits
    • Perform ECGs and obtain vital signs of patients
    • Schedule all patient research visits and procedures consistent with protocol requirements
    • Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
    • Administer questionnaires/diaries per protocol

    Qualifications

    • Level III Coordinator with at least 3 years clinical trial experience.
    • University/Bachelor’s Degree in Medicine or Life Sciences.
    • Able to coordinate complex trials independently
    • Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
    • Fluent in written and spoken English.  
    • Proficient in Microsoft Office.
    • Registered Nurse, Clinical Research Coordinator or Clinical Research Administrator

     Security Requirements

    • All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and also obtain a favorable National Agency Check (NACI).

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