Help save lives every day! Bloodworks is hiring for a Research Coordinator. In this position you will manage clinical research projects, including regulatory issues and sample and data acquisition under the general direction of a Bloodworks Member.
ANTICIPATED START DATE - JUNE 1ST
Maintain a professional relationship with subjects involved in clinical trials; ensuring their rights as research participants are protected; serve as a study participant advocate and clinical trial informational resource.
Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples (at Bloodworks or another facility), cultures, tissues and other specimens for laboratory analysis.
Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.
Perform and document all required study procedures; including but not limited to, initiation and completion when obtaining informed consent, and completion of protocol required study participant follow up.
Assist with preparation of study team and study site for sponsor audits, regulatory audits and any other type of site visit requested by study sponsor or regulatory agency.
In depth review of protocol/protocol synopsis including risk/benefits analysis and present analysis/synopsis to study team for discussion and review.
Coordinates day-to-day study related procedures including flow of documents and information
from study team at Bloodworks to sponsor and other regulatory agencies.
Perform literature reviews and analysis, providing evidence based recommendations on
research priorities and program needs.
Collaborate with research team members and other Bloodworks research staff to manage internal processes, research portfolio progress, documentation, and grant/budget information and reporting.
Consult and collaborate with other research team(s) members to ensure that ongoing and new research is aligned, supported and enhanced by the work in other areas of Bloodworks.
Interface with sponsors and other regulatory agencies to ensure timely study document submissions.
Provide feedback to management of research project progress/scope or budget changes/new research opportunities and escalating issues when they impact study participant safety, timeline, scope, quality of research or budget.
EDUCATION & EXPERIENCE:
- Bachelor’s degree in biology science or health related field or equivalent education and experience.
- Minimum three years prior experience managing clinical research projects. Experience with transfusion administration and blood banking experience is preferred.
- Experience with regulatory paperwork and the Institutional Review Boards involved with research of human subjects strongly recommended; technical writing skills desired.
- Must have strong attention to detail.
- Demonstrated effective written, verbal and interpersonal communication skills.
- Demonstrated familiarity with computerized, analysis, records management, including demonstrated computer skills using MS Office and web based data management.
- Must be highly organized, able to multi-task and work independently, take initiative to start and complete projects.
- Job Start Date Monday, June 1, 2020
- Seattle, WA, USA