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 with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest 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 Seattle Malaria Clinical Trials Center is an exciting program primarily based at Fred Hutch within the Vaccine and Infectious Disease Division (VIDD). The Fred Hutch, home to one of the world's largest research facilities, is home to the Vaccine and Infectious Disease Division (VIDD) and the Fred Hutch Prevention Center. VIDD has an overall research management structure with a documented track record to efficiently contract and facilitate complex international clinical research. VIDD is committed to support the malaria research activities and leverage related Fred Hutch programs. The Prevention Center contains a clinical facility that conducts study interviews, collects medical history and physical exam data, and supports bio specimen collection for single-facility or custom multiple-facility use studies.
The HIV Vaccine Trials Network (HVTN) is also headquartered in VIDD and provides access to substantial expertise and infrastructure for vaccine trial conduct. Staff affiliated with the HVTN Leadership and Operations, Laboratory, and Statistics and Data Management Centers are providing valuable support for the Seattle MCTC. The PI of this program Dr. Kublin is also the Executive Director of the HVTN Leadership and Operations Center.
The Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's five scientific divisions collaborate to form a unique environment for conducting basic and applied science.
We are looking for a unique individual with a strong interest in coordinating and managing clinical trials with the Seattle Malaria Clinical Trials Center. The Clinical Trials Manager (CTM) role is primarily focused on ensuring the efficient and effective implementation of malaria vaccine research studies involving human subjects, from protocol development through long-term follow-up. This includes effective project management, communicating effectively with diverse stakeholders, production of training and study specific procedure materials, developing and driving timelines and adjusting expectations as necessary. The position requires the performance of responsibilities with a high level of independence within the scope of study protocol(s) and guidelines. Position is based in Seattle, Washington and requires travel to local study sites for on-site training or assessment.
SCOPE OF RESPONSIBILITIES
The incumbent reports to the Medical Director of the Seattle MCTC. Special skills, knowledge and judgment are applied in independently managing site-level project/study operations, in developing methods and materials, and in carrying-out complex multi-site research management responsibilities. Problems and challenges that arise in the implementation of projects/studies are handled by the CTM, soliciting assistance from other stakeholders and informing the Executive Director as appropriate.
Perform some or all of the following responsibilities:
-Ensure efficient protocol start-up & implementation at study sites by facilitating or liaising between sites, other functional units, the sponsor, and others as needed.
-Manage sites related to study implementation, including the start-up timeline, enrollment, and site performance.
-In collaboration with the protocol team, develop, review, and/or revise research materials including study information sheet, trial monitoring guidelines and instructions, study aids (phone screening script, participant comprehension test, etc.), data collection instruments, educational materials, and recruitment materials.
-Develop content of data collection instruments (i.e. Case Report Forms), as negotiated with the data center and protocol team, on a protocol-by-protocol basis.
-Prepare source documents and protocol-specific training study materials for study site use.
-Develop, interpret, and administer project/study policies and procedures according to protocol, IRB, grant/contract, data management center, laboratory program and Fred Hutchinson Cancer Research Center specifications.
-Prepare site monitoring plan in collaboration with sponsor and clinical research site.
-Maintain appropriate source documentation, and develop case report forms.
-Assist with compilation and presentation of status reports to PI, clinical research team, and sponsor.
-For assigned studies, enter data accurately from source documents into electronic case report forms.
-Coordinate monitoring visits; respond to queries and other requests from study monitors.
-Prepare laboratory kits and deliver to appropriate locations on campus. Assist in transport and shipment of laboratory specimens. May also be required to oversee drug self-administration by patients, conduct non-clinical ECGs, and administer study questionnaires.
-Develop and distribute recruitment and advertising materials. Provide support for community education and recruitment for the study.
-Help to maintain the compliance of volunteers to their study regimen
-Set project goals and drive implementation timelines to ensure that all implementation activities are completed on time. Ensure collaboration and communication, including identification of milestones, issues & resolutions.
-Coordinate development of new sites. Assess capacity of study sites to conduct research protocols in accordance with SOPs, regulatory requirements, and principles of Good Clinical Practice.
-Coordinate site space and equipment planning and utilization, evaluate current project/study needs, anticipate future needs, and oversee acquisition of space/equipment.
-Represent and advocate for sites in strategic & operational discussions. Serve as the primary "go-to person" for site knowledge and site-related queries.
-Drawing on knowledge and relationships with sites' operations, provide input to protocol teams on site expertise and potential obstacles and challenges. Develop site-specific timelines and provide updates on protocol implementation such as enrollment, vaccination, and retention.
-Serve as the first point of contact when problems pertaining to a particular protocol and/or site arise. Develop plans for addressing deficiencies at study sites in collaboration with protocol team and sponsor.
-Plan and attend committee meetings, monitor activities to ensure objectives have been met within designated time frame, and coordinate follow-up activities.
-Maintain appropriate source documentation, and complete case report forms.
-Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
-Collect and assemble data for various research studies.
-Other duties as assigned.
-BA/BS in related field required.
-Previous experience in clinical trial research required.
-Clinical data collection is preferred.
-This position requires excellent organizational skills, strong problem-solving capabilities, and the ability to prioritize multiple competing tasks in a dynamic environment.
-Must be able to take direction from Medical Director as well as work independently.
-The willingness to work as part of a cohesive team is essential.
-Strong written and verbal communication skills including computer skills are necessary.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2333435-2647-3221