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    Clinical Trials Research Associate - Iowa City, United States - The University Of Iowa

    The University Of Iowa
    The University Of Iowa Iowa City, United States

    2 weeks ago

    Default job background
    Description
    BASIC FUNCTION

    Support, conduct and manage clinical trials to deliver and evaluate research protocols in patients living with HIV in the UIHC Virology Clinic under the Ryan White Program. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines and documents; human resources/leadership; and financial responsibility.

    KEY AREAS OF RESPONSIBILITY

    Protocol Development/ Management and Study Responsibilities:
    • Assist in the design, development, execution, administration and maintenance of Virology Clinic protocols and clinical studies.
    • Assist in study design and protocol development and provide input into descriptions of complex research procedures.
    • Oversee CRF development.
    • Review query reports and participate in Quality Management Group.
    • Resolve all monitoring visit issues.
    • Perform and monitor randomizations.
    • Develop complex study materials.
    • Serve as liaison to local health care practitioners, agencies and sponsors.
    Research/Clinical Activities; Subject Recruitment and Enrollment:
    • Screen, recruit, enroll and obtain informed consent for clinical trials.
    • Oversee the recruitment of subjects and scheduling of trial-related procedures.
    • Educate study participants on scope of study, potential risks and benefits, possible alternatives and study requirements for participants.
    • Relay information to principal investigator and verify student participant eligibility.
    Data Collection and Monitoring:
    • Participate in the design, development and testing of clinical research trails data systems.
    • Validate data, query resolution and make recommendations for resolution.
    • Revise and implement change in data collection.
    Regulatory Guidelines and Documents:
    • Manage and organize regulatory documentation from sites and regulatory authorities.
    • Prepare regulatory submissions.
    • Perform on-site audits or research and clinical data.
    • Monitor compliance of regulatory guidelines and proper maintenance of documents.
    • May recommend corrective action for reportable events.
    Human Resources/Leadership:
    • May provide functional and/or administrative supervision.
    • Mentor new staff under direction.
    Required Qualifications
    • A Bachelor's degree or an equivalent combination of education and experience is required.
    • Excellent written and verbal communication are required.
    • 1-3 years of related experience is required.
    Position and Application Details
    In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:

    • Resume

    • Cover Letter

    Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.

    Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.

    For additional questions, please contact michaela-davis-
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