Job Description

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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