Regulatory and Data Coordinator I

Job Description

Job Description

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 managing regulatory documents, ensuring data quality, and facilitating monitoring visits. This position is integral to maintaining compliance and ensuring smooth coordination between research teams and monitors

This role offers a hybrid work model, with a combination of on-site and remote work.

DUTIES & RESPONSIBILITIES

• Monitoring Visit Preparation : Prepare for Interim Monitoring Visits (IMVs), including conducting informed consent form (ICF) reviews and verifying source data
• Onsite Monitoring Support : Assist monitors during onsite visits by providing necessary documentation and promptly addressing queries during and after the visit.
• Follow-Up and Action Items : 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 following the initial handoff.
• IRB Submissions : Prepare and submit regulatory documents to Institutional Review Boards (IRBs) in accordance with study requirements.
• Study Initiation Packets (SIPs) : Manage the preparation, submission, and tracking of SIPs for clinical studies.
• Electronic Data Capture (EDC) : Transcribe source data into EDC systems per protocol requirements and established standards while ensuring accuracy and compliance.
• Data Verification : Maintain data integrity by comparing entered data with source documents and addressing queries in a timely manner.
• Quality Control (QC) : Assist the clinical research team in conducting quality control reviews of patient files, adhering to site and regulatory standards.
• Document Management : Prepare and scan documents into EDC systems and organizational databases to support data accessibility and regulatory compliance.
• Monitoring Visit Assistance : Collaborate with the clinical team to prepare for onsite monitoring visits for each study protocol, including reviewing ICFs and verifying source data.
• 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.

QUALIFICATIONS

Required :

Preferred :

PAY & BENEFITS

Pay Range : $27.00 / hourly - $31.00 / hourly

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

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

EEO STATEMENT

ERA Health Research provides equal employment opportunities to all without regard to race, color, religion, sex (including sexual orientation or gender identity), national origin, age, disability, genetic information, or other protected status. Applicants and employees with disabilities may be entitled to reasonable accommodations under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is an adjustment to our standard application and / or interview and / or employment process which will ensure an equal employment opportunity without imposing undue hardship on ERA Health Research. Please inform our team if you are requesting accommodation to complete any forms or otherwise participate in the application process or perform the essential functions of this role.