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    Clinical Research Manager - Houston, United States - Houston Journal of Health Law & Policy

    Houston Journal of Health Law & Policy
    Houston Journal of Health Law & Policy Houston, United States

    1 week ago

    Default job background
    Part time
    Description


    PART-TIME ASSIGNMENT

    Oversees investigator-initiated and sponsored clinical research projects. Manages graduate students, post-doctoral fellows and Clinical Lab staff in providing complex administrative duties to support the study and ensure compliance with regulations.
    1. Manage advertising and recruitment of clinical research subjects within the clinic and the community; conduct phone interviews, answer questions regarding ongoing studies, screen, and consent and enroll study subjects.
    2. Track study recruitment, enrollment, drop out, and screen failure rates.
    3. Schedule study visits and provide visit reminders.
    4. Participate in site qualification/initiation/close-out and other study-specific training.
    5. Perform limited study procedures with appropriate training; including questionnaires, automated machinery and vision testing.
    6. Assist with preparation of all IRB and Regulatory documents including but not limited to trial registrations and sponsor reports.
    7. Maintain accurate source documentation and appropriate forms including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy.
    8. Ensure research studies are conducted in accordance with Good Clinical Practice (GCP) guidelines and requirements of the University of Houston and study sponsors.
    9. Maintain licensure and certification records for all study personnel.
      10. Resolve data queries with study sponsors. Maintain supply inventory (general office and lab) and coordinate maintenance and calibration of equipment. Establish effective, collaborative working relationships with clinicians, patients, and sponsors. Provide additional support and guidance for graduate students involved in research. Performs other job-related duties as required.
    Additional Job Posting Information:
    • Resolve data queries with study sponsors.
    • Maintain supply inventory (general office and lab) and coordinate maintenance and calibration of equipment.
    • Establish effective, collaborative working relationships with clinicians, patients, and sponsors.
    • Provide additional support and guidance for graduate students involved in research.
    • Performs other job-related duties as required.
    This research coordinator will work with a large team of faculty and students in a 5 year NIH grant. This clinical researcher (RN/BSN and research experience preferred) coordinates and executes clinical research in a large and fast paced project that is repeatedly testing patients with diabetes and prediabetes. This person needs research management skills to coordinate some of the clinical testing that takes place between multiple labs, to keep track of compliance with regulations required for human clinical research, to participate in data analysis and scientific writing, and to be responsible for a number of hands on clinical and analytical procedures.

    Clinical and scientific knowledge of prediabetes, diabetes, and related cardiovascular and metabolic conditions is needed for the above activities. The study is examining the association between factors determining vision and a variety of risk factors impacted by impaired blood glucose regulation (especially cardiometabolic risk factors, inflammatory proteins, and physical inactivity).

    The work involves expertise in a specific skill set such as obtaining arterialized blood during an oral glucose tolerance test and various other research methods (see below). Although the work is part time, the hours and days of the week are inflexible because the workflow must follow the pace of recruiting and testing volunteers according to their schedules.

    Job Duties

    There are 2 general categories of duties: A) coordinating the testing, regulatory functions and good clinical practice in a clinical human research setting (#1-4 below); B) hands on execution of multiple scientific procedures, especially as it pertains to procedures required for oral glucose tolerance testing (#5-10).
    1. Candidate must have a flexible schedule and be able to accommodate the workflow of testing participants. The work schedule will be influenced by the participants' availability for testing. On many days, the candidate will be involved in performing oral glucose tolerance tests after an overnight fast and the work day will start by 7:00 AM. The completion of the work day is also variable based upon the workflow.
    2. As coordinator, this person will be responsible for keeping the principal investigator and everyone else informed on the balance of volunteers meeting criteria for the multiple categorical levels of glucose regulation and other criteria needed for the study.
    3. Ensure consent process is well controlled and collect consent forms for delivery to the principal investigator to securely store. Help schedule study visits.
    4. Be skilled in taking blood draws, including the use of intravenous catheters in the forearm and arterialized "capillary blood" sampling from the finger punctures.
    5. Proficient in the administration of oral glucose tolerance tests
      Responsible for calibration of equipment for measuring HbA1c, blood glucose, blood pressure, and VO2.
      Use of indirect calorimetry to measure carbohydrate and fat oxidation
    6. Blood pressure measurements with manual stethoscope methods
    7. Strong analytical skills for data analysis as it pertains to wearable device for tracking physical activity and sedentary behaviors with the activPAL device.
    8. Scientific writing for publishing manuscripts.
    EEO/AA

    Qualifications

    Bachelors and 5 years experience

    Requires a thorough understanding of both theoretical and practical aspects of an analytical, technical or professional discipline; or the basic knowledge of more than one professional discipline. Knowledge of the discipline is normally obtained through a formal, directly job-related 4 year degree from a college or university or an equivalent in-depth specialized training program that is directly Requires a minimum of five (5) year of directly job-related experience.

    Preferred Qualifications:
    • BSN/RN in State of Texas and preferably masters degree in a field related to metabolic health.
    • Ability to help write scientific manuscripts with at least a Masters degree in a field related to metabolism.
    • A minimum of 5 years of job-related experience in human clinical research.
    • Phlebotomy including placement of intravenous catheters.
    • Performance of oral glucose tolerance testing including arterialized blood sampling from the hand.
    • Performance of indirect calorimetry for measurement of carbohydrate and fat oxidation.
    • Metabolic and exercise testing preferably with clinical rehabilitation experience.
    • Strong analytical skills for data analysis as it pertains to tracking physical activity and sedentary time with wearable devices.
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