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