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Description

Job Summary

The Research Assistant provides Regulatory support and assists senior team members with the processing and tracking of regulatory documents related to routine submissions, such as QI/NHSR determinations and exempt IRB proposals. Also responsible for data management including entering related data into databases, cleaning/validating datasets, and supporting audit readiness. Assists in coordinating project logistics including tracking study progress, maintaining study documentation, and scheduling meetings and maintaining communication with collaborators.

Job Specific Duties

• Assists senior team members with the processing and tracking of regulatory documents related to routine submissions, such as QI/NHSR determinations and exempt IRB proposals, as assigned. 
  
• Maintains accurate documentation and timelines for all regulatory submissions and approvals. 
  
• Distributes approval letters and regulatory correspondence to study teams and stakeholders. 
  
• Enters research-related data into databases, spreadsheets, or electronic data capture systems (e.g., REDCap, Excel). 
  
• Cleans and validates datasets to ensure consistency, completeness, and accuracy prior to analysis or reporting. 
  
• Supports data documentation, version control, and audit readiness. 
  
• Tracks study progress using project management tools or trackers (e.g., timelines, milestone checklists). 
  
• Schedules and coordinates team meetings, taking and distributing meeting notes and action items. 
  
• Assists with maintaining study documentation such as protocols, data collection forms, and training logs. 
  
• Monitors deadlines for regulatory submissions, study milestones, and reporting requirements. 
  
• Communicates with research teams to ensure deliverables are completed on time and in compliance. 

Qualifications

Minimum Job Requirements

• Associates degree in health sciences or related program (OR) 2 years of research or healthcare experience
  
• 2 years of Research experience or experience working in an acute healthcare environment in a clinical or clinical support role

Knowledge, Skills, and Abilities

• Demonstrated interest in pursuing a career in the biomedical or clinical sciences.
  
• Ability to communicate in English, both verbally and in writing.
  
• Working knowledge and coursework in statistics.
  
• Familiarity with the computer based tracking systems.
  
• Able to maintain confidentiality of sensitive information.
  
• Able to relate cooperatively and constructively with co-workers.
  
• Ability to follow detailed written or verbal instructions.

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