Research Regulatory Coordinator

Position Summary

The Regulatory Coordinator is responsible for overseeing and coordinating all regulatory activities at Alabama Oncology to ensure compliance with applicable local and federal regulations, sponsor requirements, and institutional policies. This role is critical in supporting clinical trial start-up, maintenance, and closeout. The Regulatory Coordinator is responsible for communicating regulatory requirements to the site, as well as completing sponsor-required regulatory forms and IRB submissions.

Essential Duties And Responsibilities

• Manages the regulatory start up process for new studies, including gathering of essential documents and forms (e.g. 1572, Financial disclosure forms, CVs, ML, GCP etc.)
• Responsible for central IRB submissions, including Initial, Amendments, and Continuing reviews, and Study Closeout.
• Makes site-specific edits to consent forms, and reviews updated consent forms to ensure site edits are applied to new or updated consent forms. Ensures all consent forms contain HIPAA authorizations as required.
• Maintains all IRB communication, including approval letters and modification requests in the investigator site file
• Maintains accurate and complete investigator site file (site regulatory binder or e-binder) for all clinical studies in accordance with ICH-GCP, FDA regulations, and sponsor requirements.
• Schedules on-site and remote monitoring visits
• Assist with internal audits and external monitoring visits by preparing regulatory documentation and responding to findings.
• Files all sponsor communication including follow up letters, site visit letters, newsletters, and pertinent emails in the investigator site file
• Maintains study training records and delegation logs.
• Distributes training material and training logs for any study required training
• Assists Clinical Research Manager in identifying any areas for process improvement
• Ensures distribution of Safety letters to the study team
• Maintains important regulatory documents including CVs, Medical License, GCP training, Calibration records and CLIA certifications.
• Submits FDA applications to Project Facilitate for Single Patient IND or Emergency Use requests and Obtains IRB approval.
• Communicates and distributes updated consent forms, protocols and other study documents. Files all updated documents to the appropriate location so study team has access to all study documents.
• Develops and maintains standard operating procedures (SOPs) related to regulatory processes.
  
  

Additional Skills And Abilities

• Detailed knowledge of Good Clinical Practice, local, state, and applicable Federal Regulations for clinical research
• Ability to communicate effectively with peers, physicians, and management both orally and in written form.
• Excellent computer skills including Excel and Word.
• Works well independently and in a team environment
• Ability to solve complex problems and deal with a variety of situations.
• Ability to read and interpret documents such as protocols, informed consents, and regulatory documentation.
• Ability to multitask
• Strong attention to detail
• Highly organized
• Must be self-directed/self-motivated.
  
  

Certifications, Licenses, Registrations

• SOCRA or ACRP certification preferred.
  
  

Supervisory Responsibilities

• None
  
  

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. Work may require sitting for long periods of time; also stooping, bending, and stretching for files and supplies. Occasionally lifting files or paper weighing up to 30 pounds