Regulatory Associate

Primary Responsibilities

• Prepare regulatory documents for new study submissions to IRB and sponsor
• Maintain regulatory files at audit-ready status at all times by ensuring filing are up-to-date upon completion of the processing of new or revised documents
• Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements
• Receive, track, and distribute IND Safety Reports to the Principal Investigator for acknowledgement of review and file. Submit IND Safety Reports to the study-assigned IRB if submission is not handled by the sponsor
• Inform clinical operations of new study approvals including at initiation, amendments, and consent forms upon receipt. Ensure documents are distributed to the clinical team as appropriate and filed
• Communicate and update Sponsor with any revised site information and notify the IRB as required
• Liaison with IRBs on a frequent basis to ensure resolution of outstanding submissions requests
• Learn and utilize IRB electronic web portals for the processing of study submissions
• Distribute IRB approvals on new study submission to the clinical team and sponsor for resolution of questions or Board requests
• Manage the development of new Informed Consent Form drafts with the IRB, as needed, and ensure agreement with ICF language between K2 Medical Research Clinical Operations teams, IRB, and Sponsor
• Obtain Clinical assignments from the Operations teams for the development of new Delegation of Authority Logs and inform teams of missing information or needs for updates to the Logs
• Ensure protocol training is captured and returned to the regulatory department prior to the assigned staff members completing the Delegation of Authority Logs
• Ensure all regulatory binder or electronic regulatory platforms are updated at final monitoring closeout visits
• Notification to Finance team as necessary to facilitate invoices
• Inform assigned individuals of the need for archiving assistance of closed regulatory books at the defined time frame for long-term storage
• Liaison with sponsor monitors during routine and closeout monitoring visits to ensure resolution of outstanding regulatory document requirements are attended to within an appropriate time frame
• Schedule monitoring visits, prep books, and assign monitoring space as requested
• Provide team assistance on all projects as needed
• Perform ad-hoc projects and/or general office duties as necessary

Qualifications

• Prefer 2 or more years of clinical research or regulatory experience
• Bachelor's Degree and CCRP preferred