ERA Health Research · 21 hours ago
Regulatory and Data Coordinator I
Redmond, WA, US
Full-time
Hybrid
Entry Level
$25/hr - $31/hr
1+ years expERA Health Research is seeking a Full-Time Regulatory and Data Coordinator I to join our team in Redmond, WA. The Regulatory and Data Coordinator I plays a critical role in supporting clinical trial operations by managing regulatory documents, ensuring data quality, and facilitating monitoring visits.
Clinical TrialsHealth DiagnosticsMedical
Responsibilities
Prepare for Interim Monitoring Visits (IMVs), including conducting informed consent form (ICF) reviews and verifying source data
Assist monitors during onsite visits by providing necessary documentation and promptly addressing queries during and after the visit
Review IMV follow-up letters from monitors, oversee resolution of Action Items, and ensure timely completion of follow-up activities
Acquire a thorough understanding of the Regulatory Binder and manage its maintenance following the initial handoff
Prepare and submit regulatory documents to Institutional Review Boards (IRBs) in accordance with study requirements
Manage the preparation, submission, and tracking of SIPs for clinical studies
Transcribe source data into EDC systems per protocol requirements and established standards while ensuring accuracy and compliance
Maintain data integrity by comparing entered data with source documents and addressing queries in a timely manner
Assist the clinical research team in conducting quality control reviews of patient files, adhering to site and regulatory standards
Prepare and scan documents into EDC systems and organizational databases to support data accessibility and regulatory compliance
Collaborate with the clinical team to prepare for onsite monitoring visits for each study protocol, including reviewing ICFs and verifying source data
This role may perform other tasks or projects as assigned by a supervisor or manager. These additional duties will fall within the scope of the role and contribute to the overall success of the team
Qualification
Required
Bachelor's degree in Science, Healthcare, or a related field or equivalent work experience
1 - 2 years of Clinical Research Coordinator or Regulatory Coordinator or Administrative Support experience, preferably in a Clinical Research or Healthcare setting
Proficiency in Microsoft Office (Excel, Word, Outlook)
Strong attention to detail and accuracy in data management
Strong organizational and time management skills to manage multiple tasks and deadlines
Effective communication skills for liaising with monitors, clinical teams, and sponsors
Problem-solving abilities to address queries and resolve action Items effectively
Preferred
Familiarity with GCP guidelines, SOPs, and regulatory binder management
Knowledge of clinical research processes, including regulatory compliance and IRB submissions
Proficiency in EDC systems and understanding of data verification techniques
Knowledge of clinical trial terminology and regulatory standards
Benefits
Medical, dental, and vision insurance
Flexible Spending Account (FSA) and Health Savings Account (HSA) options
401k Retirement Savings Plan
Paid time off (PTO) starting at 10 days per year and 1 hour of sick leave for every 40 hours worked.
2 Floating Holidays per year
Company
ERA Health Research
ERA is a partnership of emergency physicians, urgent care clinicians and experts in the medical research field who work with sponsors to deliver results on various projects.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Kevin Hanson
Chief Operating Officer
David LaMarche
Chief Revenue Officer
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