University of Washington School of Public Health
Vaccine Trials Project Manager II - Fred Hutchinson Cancer Research Center
Closing Date: open until filled
Posted: March 15, 2017
The Cancer Immunotherapy Trials Network (CITN) is a National Cancer Institute (NCI) sponsored network initiated to stimulate the conduct of early (Phase I and Phase II) clinical trials in the area of cancer immunotherapy. The goals are to continue to build a productive network of leading investigators and institutions to implement early phase cancer immunotherapy trials, design and conduct novel biologically dictated early phase trials using agents and combinations to demonstrate proof-of-concept essential to proceed to Phase III pivotal trials, and provide high quality immunogenicity and biomarker data that elucidate mechanisms of response.
The network is coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The Network is supported by a NCI contract, and a commitment of substantial NCI services, augmented by Fred Hutchinson Cancer Research Center (FHCRC) institutional funds.
We are seeking an energetic individual with substantial background in clinical research for the position of Vaccine Trials Manager. The Vaccine Trials Manager will report directly to the CITN Administrative Director. The Vaccine Trials Manager will be responsible for working closely with CITN COSC staff to implement and manage CITN protocols in addition to helping with a variety of protocol development tasks.
SCOPE OF RESPONSIBILITIES
The Vaccine Trials Manager serves as the primary contact for the protocol by Network sites and others involved in operations.
Special skills, knowledge and judgment are applied in independently managing site-level project/study operations, in developing methods and materials, in conducting protocol training, 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 Vaccine Trials Manager, soliciting assistance from other stakeholders and informing the COSC team as appropriate.
1. Manage all operational components of several protocols, working with other groups as appropriate.
2. Actively participate in developing the protocols with an emphasis on operations. Represent the protocol team in developing, reviewing and/or revising research materials including SOPs, questionnaires, data collection instruments, educational materials, and recruitment materials in collaboration with other members of the protocol team.
3. 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
4. Ensure efficient protocol start-up & implementation at study sites by facilitating or liaising between sites, other functional units within the CITN, the developer, the sponsor and others as needed. Manage expectations for COSC, CITN Leadership and sites related to study implementation, including the start-up timeline, enrollment and site performance.
5. Serve as project/study liaison, representing the project/study to other functional units within the CITN. Serve as the first point of contact when problems pertaining to a particular protocol and/or site arise. Ensure rapid resolution of study issues/problems as they arise using appropriate internal and/or external resources. Develop plans for addressing deficiencies at study sites in collaboration with protocol team and other stakeholders within the CITN, the developer, the sponsor and others as needed. Manage expectations for COSC, CITN Leadership and sites related to study implementation, including the start-up timeline, enrollment, and site performance
6. Represent and advocate for sites in strategic & operational discussions. Serve as the primary "go-to person" for site knowledge and site-related queries.
7. 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 and retention.
8. Plan and attend committee meetings, monitor activities to ensure objectives have been met within designated time frame, and coordinate follow-up activities
9. Coordinate development of new sites as appropriate. Assess capacity of study sites to conduct research protocols in accordance with network SOPs, National Cancer Institute (NCI) requirements, and principles of Good Clinical Practice.
10. Contribute to ongoing development of procedures and practices by participating in committees and working groups as assigned.
A degree in the health sciences, e.g., an RN, NP, PA, PharmD, MHA or MBA with experience in a clinical research setting is necessary. Excellent written and verbal communication skills, flexibility and a sense of humor are essential. Strong desire to perform a variety of tasks is necessary.
- Minimum 7 years’ experience (post bachelors) or 5 years (post master’s) in a clinical research environment, including at least 5 years’ experience in the management of complex programs, activities or units
- Extensive knowledge of regulatory aspects of clinical research, e.g., IRB, HIPAA, and FDA requirements for the conduct of research.
- Direct experience in the conduct and management of clinical trials is required; additional experience with laboratory-based research or facility collaborating with laboratory scientists is desirable.
- Excellent written and oral communication skills
- Strong skills in facilitating and building consensus in an interdisciplinary team environment
- Able to multi-task effectively
- Ability to build successful working relationships with relevant network partners
- Actively seeks out new opportunities and responsibilities
- Self-motivated and able to work independently with minimal supervision using strong organizational, project and time management skills
- Strong problem solving skills
- Strong collaborative and leadership skills
- Excellent organizational skills with keen attention to detail
- Ability to prioritize competing demands to successfully meet deadlines and project milestones.
- Clinical trial monitoring or auditing experience a plus
How to Apply:
Click here to apply.