The Regulatory Affairs Assistant will facilitate document flow to ensure timely completion and distribution of study documents for all clinical trials at NEXT Oncology.

MINIMUM QUALIFICATIONS

• High school diploma or higher.
• Three year experience in a medical or research setting preferred but not required.
• Proficiency with Microsoft Word and Adobe Acrobat.
• Excellent verbal and written communication skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Give tours of NEXT Oncology to clinical trial Sponsors and other visitors as applicable.
• Complete feasibility questionnaires for proposed clinical trials as needed.
• Set up various meetings (Protocol Review and Feasibility Committee, Site Qualification Visits, Site Initiation Visits, etc.) as needed.
• Enter study-specific information (such as but not limited to, study title, assigned staff, documents received from Sponsor, IRB submission/approval dates, etc.) in internal FileMaker database to provide a complete history of each clinical trial.
• Maintain official regulatory files in our electronic regulatory files system (eDOCS) for clinical trials being conducted at NEXT Oncology once a study is approved by the IRB.
• Distribute new study documents to appropriate staff when received and provide submission status of the items.
• Distribute IRB review/approval documents to appropriate study members (internal and external) within 24-hours from IRB receipt.
• Set up access for NEXT Oncology staff in eDOCS to ensure most current documents are available to all staff.
• Set up access for Sponsors and their representatives in eDOCS once the Site Initiation Visit has occurred.
• Complete various documents (such as but not limited to: Delegation of Authority Logs, Form FDA 1572s, Financial Disclosure Forms, etc.) for clinical studies being conducted at NEXT Oncology.
• Maintain current certifications and ranges for all laboratories being used in the conduct of clinical trials at NEXT Oncology.
• Maintain current CVs and Medical Licenses for investigators.
• Maintain current training documents (GCP, HRS, etc.) in eDOCS for all NEXT Oncology staff.
• Work with Research Coordinators to ensure training documentation provided to Regulatory Department is accurate.
• Receive incoming correspondence/files and review/forward to appropriate staff.
• Attend Phase I meetings, Site Qualification Visit meetings, Site Initiation Visit meetings, and other meetings as applicable.
• Perform a variety of administrative duties including but not limited to: answering phones; faxing and filing of confidential documents; and basic Internet and email utilization.
• Provide excellent customer service to all internal and external customers.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Requires sitting and talking on the telephone for extended periods of time.
• Requires corrected vision and hearing to normal range.
• Requires outgoing and friendly personality for interaction with internal and external parties.

SUPERVISION

The Regulatory Affairs Assistant reports to the Regulatory Affairs Coordinator.