Clinical Research Coordinator 1

University of Washington•Campus, IL

46d•Onsite

About The Position

Reporting to the Research Manager this position promotes the research objectives of the Melanoma/Renal Cell research program in the Division of Hematology and Oncology. This position works with the Division of Hematology and Oncology faculty to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for implementing multiple research projects to test the hypotheses in human subjects. This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. With guidance this position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Division of Oncology. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done with limited assistance and in a resourceful manner to expedite the Division's research objectives. This position is also responsible for participating in and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from pharmaceutical companies, health care providers and terminally ill patients in a manner that well represents the University of Washington and its associated institution (FHCC) The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides contributions to research development and implementation for the Division of Oncology. It is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the Division of Oncology. Furthermore, at any one time up to 100 oncology patients from various Phase I, II and III oncology trials will be enrolled on these clinical trials.

Requirements

Bachelor's degree in a related field and one year of relevant experience.
Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Nice To Haves

Demonstrated understanding of medical terminology
Strong computer skills and experience with data entry and databases
Strong attention to detail and ability to organize work
Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives
Demonstrated ability to work independently and to carry out complex tasks
Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire
Knowledge of oncology practice and terminology
Prior working experience at the UWMC or FHCC
Prior experience in basic processing laboratory samples
Competency in MS Office software
Knowledge of HIPAA regulations
Knowledge of GCP (Good Clinical Practice)

Responsibilities

Protocol Management - 50%
With minimal guidance, implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).
Develop, document and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
Work with Data Coordinator and Research Manager to design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives.
Complete source documents in a timely manner.
Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board and study sponsors are timely, accurate and satisfy applicable regulations.
With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.
Work collaboratively with research team (data coordinator, regulatory coordinator, research assistant) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Research Study Subject Management - 45%
Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection.
Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol).
Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for oncology clinical trials.
Communicate timely and accurate information to research study subjects about study participation and visits.
Understand clinical trial budget and billing plan for patients enrolled on clinical trials.
Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance.
Assist in financial audits as necessary.
Administrative - 5%
Prepare interim reports for principal investigators, industry sponsors, and institutional review board to ensure that each project is moving toward timely completion.
Perform other related tasks as assigned