Research Regulatory Specialist

Major Responsibilities:

• Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies.
• Plans, develops and prepares all required regulatory documents, including all initial, amendments and continuing reviews to the IRB, FDA, Office for Human Resource Protections (OHRP), and other regulatory bodies, including central offices of cooperative group studies, and sponsors where necessary. Supports submissions to ancillary committees.
• Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions and ensure timely review and approval in compliance with local and external IRB SOPs and other regulatory agency requirements.
• Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout.
• Collaborates with study team to ensure implementation of amendments, awareness of safety and protocol changes, and version control management.
• Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events.
• Maintains study level documentation for all studies, including those that are complex in nature. Ensure files are audit ready. Monitors compliance required documentation.
• Enters and maintains study information and regulatory approvals in electronic systems.
• Provides guidance and training to research staff to ensure compliance with highly complex, highly specialized regulations and guidance associated with clinical research studies and trials involving human subjects. Attends and participates in educational programs, meetings and assigned committees.
• Participates in the development and implementation of quality improvement and quality assurance activities. Other duties as assigned.

Licensure, Registration, and/or Certification Required:

• None Required.

Education Required:

• Bachelor's Degree (or equivalent knowledge) in Business or related field.
• Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field.

Experience Required:

• Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge.

Knowledge, Skills & Abilities Required:

• Knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents.
• Knowledge of policies, procedures and SOPs specifically related to regulatory documents.
• Knowledge of clinical trials and terminology required.
• Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines. Ability to problem solve and work independently with a high degree to accuracy and attention to detail.
• Good understanding of computer software, Microsoft Office, Word, Excel, Adobe, and Teams
• Ability to travel between facilities as needed.

Physical Requirements and Working Conditions:

• Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently during the work shift.
• Must have functional sight and hearing.
• Exposed to a normal office environment.
• Position may require travel. May be exposed to road and weather hazards.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.