Regulatory and Data Coordinator I

ERA 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 supporting study activation, managing regulatory documents and processes, ensuring data quality, and facilitating monitoring visit preparation and follow-up. This position is integral to maintaining compliance and ensuring smooth coordination between research teams, CRAs, and sponsors. This role offers a hybrid work model, with a combination of on-site and remote work. During the first few months, the employee may be required to work on-site for training and onboarding purposes., Regulatory Expertise: Serve as the subject matter expert for regulatory aspects of clinical study conduct.

Study Activation: Manage the preparation, submission, and tracking of SIPs for clinical studies. Collect essential regulatory documents, prepare and submit documents to the IRB for approval prior to study initiation, set up study in clinical trial management system, and partner with clinical operations team on site initiation.

Monitoring Visits: 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.

Regulatory Binder Management: Acquire a thorough understanding of the Regulatory Binder and manage its maintenance throughout the study. Assist the clinical research team in conducting quality control reviews of patient files, adhering to site and regulatory standards.

IRB Submissions: Prepare and submit regulatory documents to Institutional Review Boards (IRBs) in accordance with study requirements.

Electronic Data Capture (EDC): Collaborate with clinical operations team to 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.

Document Management: Prepare and scan documents into EDC systems and organizational databases to support data accessibility and regulatory compliance.

Other Duties: 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.

• Bachelor’s degree in Science, Healthcare, Compliance/Regulatory or a related field or equivalent work experience
• 1 - 2 years of clinical research and regulatory support in a healthcare or clinical research setting
• Knowledge of clinical research processes, including regulatory compliance and IRB submissions
• Familiarity with GCP guidelines, SOPs, and regulatory binder management
• Proficiency in EDC systems and understanding of data verification techniques
• Knowledge of clinical trial terminology and regulatory standards
• 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

Pulled from the full job description

• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Health savings account
• Dental insurance
• Flexible spending account, Pay Range: $25.00 - $28.00/hourly

Pay is based upon candidate experience and qualifications, as well as market and business considerations.

ERA Health Research provides eligible employees with an opportunity to enroll in a comprehensive benefits package which includes:

• Medical, dental, and vision insurance
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options
• 401k Retirement Savings Plan
• Paid time off (PTO) starting at10 days per year and 1 hour of sick leave for every 40 hours worked.
• Two Floating Holidays per year