University of Washington School of Public Health
Clinical Affairs Safety Associate II - Fred Hutchinson Cancer Research Center
Closing Date: open until filled
Posted: January 18, 2019
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. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.
The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Clinical Safety Associate (CSA). The CSA functions as an internal subject matter expert (SME) providing consultation on protocol safety data and data management. The CSA monitors clinical trial data for completeness, accuracy, protocol, safety and regulatory compliance.
Please note: This position is on-site in Seattle, WA. We cannot accommodate 100% remote work for this role at this time.
The CSA participates in protocol development, case report form (CRF) and database design to ensure all required safety related data are adequately represented and captured. The CSA will monitor clinical trial safety data for compliance in reporting, completeness, and accuracy. The CSA will assist in site safety data collection training as needed during study implementation and will actively monitor study data throughout the life of the trial for safety compliance and data accuracy. The CSA functions with minimal supervision and demonstrated decision making ensuring that the protocol requirements and clinical data safety needs are met.
- Participate in protocol development activities, including working with other protocol team members to develop clinical trial safety monitoring and reporting strategies and tools, including CRFs and the trial database.
- Collaborate with Protocol Safety Review Teams (PSRT) and/or Safety Monitors to ensure appropriate clinical safety report design and accuracy.
- Monitor and work with sites, including providing training, to ensure clinical data completeness, accuracy and alignment with regulatory reporting requirements.
- Function as an active member of the PSRT, facilitating PSRT data reviews, including preparing, reviewing and distributing safety reports
- Provide ongoing consultation on protocol safety issues to protocol teams, network partners, sponsors and internal partners.
- Reconcile AE data in the clinical database and SAE/EAE data in the safety database, work with collaborators to resolve discrepancies, and complete data reconciliation reporting requirements.
- Conduct clinical trial clinical data closeout activities.
- Manage safety issues identified by the PSRT and/or Safety Monitors to and/or from sites. Obtain clarification and additional information as necessary
- Coordinate modifications of safety reports & safety monitoring system per PSRT or Safety Monitors request or protocol modification
- Perform clinical review and evaluation of received reference ranges from the labs in accordance with our Standard Operating Procedures (SOP) processes
- In collaboration with internal partners, safety physicians and PSRT, query sites for clarification of clinical data, and work with sites to resolve these queries
- Work in collaboration with internal and external partners to meet protocol milestones such as SMC, DSMB, and FDA reporting deadlines.
- Send timely notification to the safety physicians and/or PSRT regarding safety events that meet specific criteria, as agreed upon per protocol requirements
- Conduct all job duties according to appropriate SOPs and within the context of Good Clinical Practice (GCP) guidelines.
- Healthcare Professional Degree - RN/BSN/MSN, NP, PA, RPh/PharmD/PhD/B.Pharm or MD
- One year clinical trial experience required
- Familiarity with clinical trials safety data collection practices, clinical data and adverse event reporting and regulatory requirements strongly preferred.
- Excellent written and verbal communication skills.
- Position requires a high level of attention to detail and organization.
- Demonstrated technical skills (EDC systems, MS Excel, Word, PowerPoint), Medidata RAVE desired
- Demonstrated ability to work independently and take initiative in a dynamic environment
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