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Clinical/Health Care Research Associate

Company: The University of Iowa
Location: Iowa City
Posted on: November 19, 2020

Job Description:


The University of Iowa Department of Radiation Oncology is seeking a Clinical/Health Care Research Associate to coordinate research activities in the support of Clinical Trials. The incumbent will assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Screen, recruit, enroll and obtain informed consent for clinical research activities. Participate in the design, development, and testing of clinical research trial data systems. Manage and organize regulatory documentation.

CHARACTERISTIC DUTIES AND RESPONSIBILITIES


  • Oversee operations of clinical research studies including the recruitment, coordination and scheduling of subject participation and procedures per protocol requirements..

  • Assist in the development of protocols and clinical studies and provide input into complex research procedures.

  • Perform physical exams and follow-up visits including expanded nursing procedures, as well as, reviewing medical histories, test results and symptoms to determine eligibility or need for treatment, follow-up and/or referral per Radiation Oncology research protocols. Provide patient education.

  • Assist physicians in determining eligibility of patients for research protocols.

  • Assist in obtaining patient consent to enter protocols and counsel patients and families regarding investigational therapy.

  • Administer study medication and identify adverse reactions.

  • Enter patients on protocol, ensuring that all prerequisites have been completed and are within the required parameters.

  • Assist patients with problems related to their protocol therapy such as consultation when calling concerns related to emergency evaluation in the case of side effects, assisting with emotional problems or other related issues.

  • Coordinate patient care needs and obtain follow-up information from local physicians or laboratories or appropriate healthcare providers per established research protocols.

  • Serve as a liaison to local physicians/hospitals and collaborating institutions to facilitate care of protocol patients when hospitalized at outside institutions. Obtain documentation of hospitalizations, as well as provide notification to the Principal Investigator, Study Sponsor and FDA as required per protocol.

  • Oversee CRF development.

  • Organize clinic/study procedures, follow study participants and manage collection of accurate data in a timely manner, keeping data and documentation secure and confidential.

  • Review query reports.

  • Resolve all monitoring visit issues.

  • Perform and monitor randomizations.

  • Develop complex study materials.

  • Coordinate services and referrals with other departments participating in the clinical research.

  • Maintain records and services provided and work within individual protocol budgets.

  • Serve as a liaison to the University Business Office to identify specific patient tests and procedures paid for by study sponsors and assist with questions related to billing for protocol treatment procedures.

  • Assist with the preparation and present IRB information for approval.

  • Perform critical analysis of literature relevant to the clinical trials.

  • Assist in validating data and make recommendations.

  • Assist with statistical analysis of data and preparation of data for computer analysis.

  • Use evaluation data to revise and implement change.

  • Assist in the preparation of research papers and manuscripts for publication and presentation at conferences and workshops, and in the writing of project reports, articles and other documents for submission to study sponsors.

  • Maintain effective working relationships with faculty, staff, students and the public.


    University of Iowa Hospitals & Clinics—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patient s. Simply stated, our mission is: Changing Medicine. Changing Lives.®
    Percent of Time: 100%Schedule: Monday through Friday, 8:00 AM to 5:00 PM
    Benefits Highlights:• Regular salaried position located in Iowa City, Iowa• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans• For more information about Why Iowa? click
    QUALIFICATIONS

    • A Master's degree in Nursing or an equivalent combination of education and experience that is directly related to the duties of the position is required. An equivalent combination option must include a BSN plus professional nursing experience.

    • A valid Iowa Registered Nurse license is required.

    • Must have the ability to translate, adapt and apply knowledge and perform specialized research in a nursing field of discipline.

    • Considerable (3-5 years) experience with and participation on clinical trials is required.

    • Previous research protocol management experience including single and multi-institutional studies is required.

    • Experience with protocol therapy and medical research data management is required.

    • Knowledge of regulatory guidelines and procedures is required.

    • Overnight and weekend travel may be required.

    • Excellent written and verbal communication skills are required.


      HIGHLY DESIRABLE QUALIFICATIONS

      • Previous recent clinical experience in Adult Radiation Oncology.

      • Oncology Nurse Certification highly desirable.

      • Recent experience with Investigational infusions.


        DESIRABLE QUALIFICATIONS

        • Knowledge of Radiation Oncology.

        • Previous experience with Investigator-initiated, cooperative group and Industrial Clinical Trials.

        • Excellent interpersonal skills.

        • Excellent organizational skills.


          Successful candidates will be subject to a credential and criminal background check. This position is not eligible for University sponsorship for employment authorization.

          Additional Information

          • Classification Title: Clinical/HC Research Associate
          • Staff Type: Professional and Scientific
          • Schedule: Full-time

            Compensation

            • Pay Level: 5A
            • Starting Salary Minimum: 50,012

              Contact Information

              • Organization: Healthcare
              • Contact Name: Joleen Timm
              • Contact Email: joleen-timm@uiowa.edu

                The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.


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Keywords: The University of Iowa, Iowa City , Clinical/Health Care Research Associate, Healthcare , Iowa City, Iowa

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