Saralynn Chen
Seattle,WA
Summary
Detail-oriented and highly motivated clinical researcher with strong expertise in supporting all stages of clinical trials, from start-up through maintenance to closeout. Exceptional organizational skills and a commitment to quality performance to ensure consistent deadline achievement while fostering effective collaboration across teams.
Overview
7
7
years of professional experience
Work History
Senior Associate Study Manager
ICON Strategic Solutions
01.2022 - Current
- Work with the clinical trial management staff to support the execution and monitoring of clinical studies and trial deliverables in accordance with ICH-GCP, standard operating procedures, and all applicable regulations
- Participate in study planning and start-up activities including vendor management, project management, and coordination of study and implementation plans
- Collaborate with study team members to prepare materials for site initiation trainings and investigator meetings
- Support inspection readiness activities such as maintaining eTMF (Veeva Vault) timeliness and quality metrics
- Monitor progress of studies, data flow, and identify study-related trends and work to implement corrective actions when necessary.
- Participate in study team meetings and take minutes as neede
Senior Clinical Research Data Coordinator
University of Washington
01.2019 - 01.2022
- Manage data entry processes for over 10 Phase One oncology clinical research trials
- Ensure detailed protocol research requirements are met through tracking and managing treatment schedules for clinical trial patients
- Utilize ORCA & EPIC to print patient vitals, labs, and study drug administration records and file patient charts within the protocol window
- Collaborate with pharmaceutical sponsor representatives to ensure accuracy and quality of data entered into the electronic data-capture systems (Medidata RAVE, InForm, Medrio)
- Resolve data discrepancy queries issued by sponsor representatives for each clinical trial by cross checking information in the electronic medical record databases
- Perform protocol mandated electrocardiograms
- Experienced in HIPAA and GCP guidelines to protect the rights, safety, and well-being of human subjects
Education
Bachelor of Science - Biology: Ecology, Evolution, Conservation
University of Washington
Seattle, WA06-2019
Timeline
Senior Associate Study Manager
ICON Strategic Solutions
01.2022 - Current
Senior Clinical Research Data Coordinator
University of Washington
01.2019 - 01.2022
Bachelor of Science - Biology: Ecology, Evolution, Conservation
University of Washington