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Clinical Research Coordinator I
Company | Fred Hutch |
Address | Seattle, WA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Hospitals and Health Care |
Expires | 2023-09-26 |
Posted at | 8 months ago |
Overview
- Other duties as assigned
- Facilitate activation of clinical trial in partner institution systems and adjust activation procedures as partner systems change
- Provide input regarding IRB correspondence and regulatory documentation
- Liaise with investigators, industry sponsors, and other study teams to ensure each clinical trial under your management operates efficiently
- Assist with completion of CRF (Case Report Forms), extract data from medical charts of partner institutions for multiple studies
- Work with other members of the clinical team to understand the timing and implications of their operating requirements to ensure accurate and effectively management of the clinical trials.
- Participate in weekly clinical meeting discussion of protocol status and patient reports
- Provide back up for other clinical team members as needed.
- Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy
- Work proactively with central offices, clinic partners, faculty members and research collaborators to ensure all protocol requirements can be met upon implementation, throughout the study, and to close out of the study
- Coordinate sample collection, schedule study related clinic procedures such as blood draws, infusions and imaging according to protocol requirements; coordinate with clinic staff to ensure proper documentation and timing of research-related procedures
- Following patients to be enrolled on protocols making sure they meet eligibility criteria.
- Maintenance and tracking of all patients enrolled on a clinical study in CTMS/OnCore
- Assist with preparing start-up documentation including IRB documents, eligibility checklists, study procedures/SOPs, study-specific clinic orders and study calendars
- Willingness to positively adapt to changing environments, data systems, compliance requirements and general competing priorities from internal and external sources
- Demonstrated knowledge of how to synthesis study conduct.
- Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
- Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
- Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
- High school diploma or equivalent.
- Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
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