Benaroya Research Institute at Virginia Mason (BRI) is an independent non-profit organization within Virginia Mason Franciscan Health. We collaborate with clinicians to accelerate the path from innovative lab discoveries to life-changing patient care.
Responsibilities:
Understand and manage approximately 125 research projects in a variety of disease types:
- Development, execution, coordination, oversight, administration and/or tracking of multiple large-scale Federal research projects, grants and collaborative research agreements.
- Manage, mentor, train, and support research staff of 7-10 people.
- Manage interactions with up to 50 Industry Sponsors and Contract Research Organizations and and liaise with up to 12 internal stakeholder departments.
- Understand and organize protocols and align with standard clinical care and flow.
- Manage milestone planning, study operations and internal and external reporting.
- Operate with a high degree of independence and deploy strategies to successfully resolve problems.
- Effectively communicate with internal and external investigators/researchers, clinic professional staff, and administrative support staff.
- Create appropriate and realistic timelines, monitor progress, and troubleshoot with team members to avoid delays.
- Lead project team in recruitment activities and study enrollment.
- Use expertise in oncology clinical research and demonstrate subject level expertise of various disease states/types under clinical investigation.
- Demonstrate a strong knowledge base in varied types of research including the following: retrospective chart reviews, registries, repositories, preventive trials, investigative device trials, interventional trials, intra-tumoral research and gene therapy.
Management and oversight of financial solvency of research projects:
- Plan, create, negotiate, and administer budgets for Industry-Sponsor funded, NIH funded and Investigator-Initiated clinical trials.
- Oversight of financial solvency for the clinical research studies, including oversight and management of budgeting, invoicing, amending budgets and contracts, and working with VM/BRI departments to ensure appropriate billing of research procedures.
- Understand NIH funding guidelines, assist with grant applications and create budgets for NIH-supported trials.
Develop, improve, and implement processes:
- Develop and implement standards and procedures for technical staff.
- Direct and participate in standard process development activities and understand lean processes.
Regulatory oversight, management, and compliance:
- Complete IRB and IBC applications and support integration and use of investigational agents within VM.
- Support Investigational New Drug (IND) applications, IND Expanded Use applications, Investigational Device Exemption (IDE) applications and Humanitarian Use Device (HUD) or Humanitarian Device Exemption (HDE) applications.
- Interpret and comply with Institutional Review Board (IRB) regulatory and funding agency requirements.
- Oversight of staff submitting, documenting, and reporting items to the IRB, Food & Drug Administration (FDA), Institutional Biosafety Committee (IBC), National Institutes of Health (NIH) and other agencies.
- Work with varying levels of employees and professionals in multiple departments to review research for problem analysis and discuss status and/or determine changes to scientific and technical goals as needed.
- Create data management plans for IIT’s and have oversight of research data analysts to execute data plan.
Requirements:
- Bachelor’s degree in biological science, clinical research, health science or closely related field plus five years of experience in clinical research, OR master’s degree and three years of experience.
- Experience must include two years related to oncology clinical research.
- Must have experience with operational management, database functionalities (data capture, exporting and reporting).
- Must have experience with Medical Records, including how to read and interpret them, extract information, and comply with privacy requirements.
- Must have Clinical Practice and Biomedical Research Training using the CITI Program or equivalent.
Visit https://careers-benaroyaresearch.icims.com/jobs to apply for this position.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.