Regulatory and Data Coordinator I

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 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 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

• Bachelor’s degree in Science , Healthcare, or a related field or equivalent work experience
• 1 - 2 years of clinical research and regulatory support in a healthcare or clinical research setting
• Data entry experience
• 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
• 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

PAY & BENEFITS

Pay Range: $25.00 - $31.00

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 daysper year and 1 hour of sick leave for every40 hoursworked.
• 2 Floating Holidays per year

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.