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Clinical and Translational Research Center Study Coordination

Director: Samuels, Mary, MD

Summary:

The CTRC Study Coordinator team offers support to adult and pediatric studies, investigator initiated or industry sponsored, across OHSU and the Portland Veterans Administration Medical Centers. Our team is made up of highly motivated, experienced, professional individuals who receive extensive training in regulatory compliance and study coordination. This includes a Pediatric nurse dedicated to coordinating all in-patient and outpatient pediatric studies. CTRC Study Coordinators work collaboratively with investigators to ensure the integrity and success of the research study. When submitting a grant application, include the CTRC Study Coordinator costs in the budget. OCTRI may be able to subsidize -- partially or in full -- the costs of the services for certain investigator-initiated studies.


CTRC Study Coordinator Services

Coordinate adult and pediatric studies
OHSU, VA, and community-based studies
Oversee all study activities per protocol
Recruitment support
Consent and assent (pediatric) participants
Point of care tasks including vitals, phlebotomy, glucose and pregnancy testing
Patient education and compliance checks
Creation of study documents
Survey development and administration
Data extraction, collection, entry, and follow-up
Monitor progress of research activities and prepare reports
Coordinate site and monitor visits
IRB and regulatory compliance

Affiliations:

People:

    Member: Farrar, Carrie, MPH
    Role: Clinical and Translational Research Center Study Coordinator Unit Manager

Resources:

Services

  • Drug Compliance, Coordination & Reconciliation ( Support service )

    "OCTRI study coordinators can work with the OHSU Research Pharmacy to maintain the necessary stock of medications required for the protocol.

    Industry-sponsored studies often require regular check-ins with the Research Pharmacy and sponsor or drug supplier. Study coordinators can manage this important aspect of clinical trials."

  • Ongoing Compliance Documentation ( Support service )

    Conducting research involving human subjects requires review and approval by the Institutional Review Board (IRB). Federal, state, and institutional policies govern this process. However, it's not necessary for investigators to become experts in these regulations. OCTRI can guide investigators and study staff through this process. OCTRI can assist with the initial IRB submission at both OHSU, Kaiser Permanente, and the Portland Veterans Administration Medical Center.

    OCTRI study coordinators are experienced in submitting ongoing documentation to the IRB. This documentation includes: protocol modifications, adverse events (AEs) , and the Continuing Review Questionnaire (CRQ).

  • Preparation of Study Documentation ( Support service )

    "OCTRI study coordinators prepare the following documentation as part of study set-up:

    Regulatory binder
    Source documentation
    Participant visit packets
    Additional documentation based on the protocol's unique needs

    Study coordinators can also train non-OCTRI study staff, conduct in-services for partnering departments (most often the Research Pharmacy and labs), and coordinate site visits for industry-sponsored studies."

  • Recruiting, Scheduling & Consenting Study Participants ( Support service )

    "OCTRI study coordinators are prepared to assist with participant interaction from recruitment through consenting and data and specimen collection. Study coordinators are experienced in standard and novel recruitment methods, and they have a track record of successfully recruiting participants for studies, including child health protocols, with very stringent exclusion criteria. Coordinators can also manage the entire participant scheduling and consenting process.

    OCTRI has pediatric RN study coordinators who work to provide unique support for pediatric and child health studies."

  • Survey Administration & Data Entry ( Support service )

    "OCTRI study coordinators are trained to administer a wide variety of written, oral, and computer-based surveys, questionnaires, and tests. Coordinators are also prepared to learn the administration and scoring of new instruments based on specific protocols.

    In addition to survey administration, study coordinators are trained in efficient and accurate data entry. Coordinators are committed to meeting the precise needs of investigators and study statisticians. Study coordinators meet with investigators and statisticians to confirm data input and output.

    Study coordinators are highly experienced in data entry in Excel and REDCap databases. REDCap databases are secure, web-based databases designed for research studies. OCTRI's data management experts can assist investigators and study staff in deploying a REDCap database quickly and easy. REDCap also provides a survey tool similar to SurveyMonkey."


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Last updated: 2013-02-28T11:49:33.042-06:00

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The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016