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Clinical Research Coordinator I, LTFU

Company: Fred Hutch
Location: Seattle
Posted on: June 14, 2018

Job Description:

Overview Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here The Clinical Research Coordinator, LTFU is responsible for day-to-day coordination of long term follow up (LTFU) for Phase I gene therapy clinical trials. This individual will work under the supervision of the Clinical Research Coordinator Supervisor and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Responsibilities The Clinical Research Coordinator will be responsible for the following: Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of LTFU in accordance with Good Clinical Practice guidelines, regulatory policies/guidelines, and institutional policies. Prepare study templates and documentation including LTFU checklists, study-specific clinic orders, study calendars, data collection tools, and study reference materials. Revise and utilize tools as necessary. Work closely with the clinical research operations trial coordinator and director of LTFU to develop the LTFU program including SOPs, operational templates, and other common guidelines. Initiate scheduling of patient clinic visits and ensure that all clinical procedures, lab tests, and other protocol-specific activities are completed as outlined in the protocols. Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies. Coordinate research sample collections with research laboratory staff. Maintain appropriate source documentation and complete or assist with accurate data entry into case report forms in a timely manner. Coordinate monitoring visits and respond to queries and other requests from study monitors. Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy. Other duties that may be required: Serve as project/study liaison, representing the project/study to other Center departments, funding sources, affiliated individuals or institutions, and outside organizations. Maintain or assist in maintaining IRB correspondence and study regulatory documentation. Prepare or assist in preparing annual renewals, protocol and informed consent form modifications, serious adverse event reports, and other study reports. Prepare or assist in preparing reports for Principal Investigator, Investigational New Drug Sponsor, FDA, IRB, NIH OSP, or industry sponsors. Other duties as assigned. Qualifications BA/BS in related field required with a minimum of two to three years post-bachelor's work. Experience in clinical oncology research is preferred. Strong written and verbal communication skills, organizational skills, problem-solving and multi-tasking abilities are required. Collaborative focus is essential. Must have ability to work independently and take initiative in a dynamic environment. Must exhibit excellent dependability and ability to adapt and respond appropriately to competing priorities. Our Commitment to Diversity We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at (see application details) or by calling (see application details).

Keywords: Fred Hutch, Seattle, Clinical Research Coordinator I, LTFU, Healthcare, Seattle, Washington

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