21 days old

Research Specialist II (Human Subject / Patient Clinical Trials)

Kaiser Permanente
Aurora, CO 80012

Responsible for research infrastructure and implementation support of studies, including patient recruitment, enrollment, monitoring and follow-up. Collaborates with other study personnel. Coordinates activities as requested to assure completion in a quality and timely manner, consistent with protocols and procedures in the project plan. Ensures compliance with research subject enrollment and data collection protocols. Responsible for the documentation and reporting of adverse events. As a member of the IHR, you will be held accountable for compliance with federal, state, institutional, and departmental requirements. You will be trained on Health Insurance Portability and Accountability Act (HIPAA) for Researchers and on Human Research Participant Protection; completion of training will be documented.

Essential Responsibilities:
  • Independently develops and designs research data collection tools, working with clinic staff to ensure ease of research project implementation, and project start up.
  • With minimal direction from Project Manager and investigators, creates information materials for study subjects, which may include courses, counseling, printed materials, electronic media or training plans. Counsels and conducts educational classes for study patients. Delivers the study intervention that may include obtaining patient informed consent, providing health education or counseling to participants.
  • With minimal direction from investigator and/or project manager, coordinates day-to-day progress of research studies. Records research data in case report form, if required. Responsible for the documentation and reporting of adverse events. Conducts focus groups, qualitative interviews or other direct data gathering, if required. Conducts research surveys. Reviews surveys for accuracy; edits and codes data. Monitors and follows-up on research subjects.
  • Documents all research subject visits, site visits, study meetings. Assure timely and accurate data handling. Assists in data quality monitoring. Assist in designing data collection or abstraction forms. Communicates with project manager or investigator and supervisor regarding study task progress.
  • Adhere to federal and local regulations and KPCO Standard Operating Procedures governing research. Follow the IRB approved protocols on federally funded grants as well as on internally funded projects. Adhere to the research protocols for maintaining HIPAA compliance when accessing, manipulating, storing, and transferring data. ¬†Partner with Investigators to adhere to the research requirements outlined in the study protocol and data use agreements report all violation/deviations immediately to the Investigator and IRB.
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    Posted: 2019-10-02 Expires: 2019-11-22

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    Research Specialist II (Human Subject / Patient Clinical Trials)

    Kaiser Permanente
    Aurora, CO 80012

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