• Clinical Study Mgr - 1 - Kansas City

    Job Locations (All) | US-KS-Lenexa
    Posted Date 5 days ago(11/9/2018 12:28 PM)
  • Overview

    Organizes clinical studies and local teams for clinical research studies. Ensures studies are completed in accordance with study protocol, contract, and clients’ expectations. Serves as clinic contact for the study Sponsor and all internal groups.


    Responsible for assessing, preparing, and implementing the studies for the clinic in order to ensure and guarantee a timely and high-quality study output. This involves:

    • Reviewing and assessing the protocol, clinic budget, Case Report Forms, Informed Consent Forms and volunteer information.
    • Conducting a feasibility analysis (feasibility); workload, availability and workload for volunteers, practicability and personnel required and create a risk analysis and draw up contingency plans for one’s field of responsibility.
    • Serving as a liaison between all clinic groups and the applicable clinic management -
    • Ensuring proper study specific training and may ensuring proper delegation is completed.
    • Advising the Project Manager to ensure that he/she is aware of all preconditions, for timely and high quality implementation of the study in the clinics.
    • Ensuring timely availability of materials and equipment (and making corresponding instructions) and approving invoices.
    • Maintaining contact with the client concerning clinic related questions and updates.
    • Organizing and chairing the pre-study and during-study meetings and perform necessary actions.
    • Setting up and hosting clinic specific meetings (EDS-US) and preparing and participating in (EDS-NL) with the client such as Site Initiation Visits, Monitoring Visits (in cooperation with data entry staff).
    • May setting up, coordinating and communicates with outside vendors for the study.
    • Communicating any changes in scope or cost to the PM and clinic management.
    • Escalating issues and major deviations to the applicable clinic management
    • May Assigning randomization to study participants prior to first dose and is present at first dose.
    • May Preparing or reviewing and approving Source Documents.
    • Preparing of Clinic documents (including Study specific instructions, briefing, information card...).
    • Ensuring proper sampling, collection and transmission of research data / samples.
    • Taking effective action to prevent and to recover errors in the output of clinical studies and to prevent recurrence.
    • Writing Notes to File and Investigational Reports.
    • Informing the volunteers about the study at the check-in in the Clinic and during the study.
    • Planning and coordinating of outpatient visits.
    • Monitoring the study timelines.
    • May Ensure all documents are submitted to the IRB/METC.
    • Monitoring the study output by clinic staff according to protocol and internal procedures.
    • Ensuring quality in the execution of the study in the Clinic.

    Responsible for the closing of the clinical conduct of the study. This involves:

    • Coordinating restitution and / or storage of study materials, equipment and documents.
    • Evaluating the study.
    • Organizing and chairing the post-study PTO, to study evaluation and perform necessary actions.


    • EDS-US: 1-3 years’ experience in a position with organizational/management duties were a major part of role.
    • EDS-NL: At least 1 year as Medical Research Associate (H.B.O. + (higher vocational) education level)

    • Bachelor’s degree or M.B.O. level (Secondary vocational education)
    • Specialization in a medical area. (EDS-NL)

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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