BSS Human Research Protection Program Analyst, Part Time

• Process RDC and IRB submissions as needed
• Complete pre-reviews of research protocols
• Prepare meeting materials and minutes
• Issue IRB outcome letters
• Manage studies and the submission process in iRIS
• Support IRB leadership in management of the full IRB/RDC review process during meetings
• Coordinate the orientation, education and training of board members
• Assist with Association for the Accreditation of Human Research Protection Program accreditation processes
• Develop and update documents, written materials and procedures for various assigned projects
• Coordinate the collection of information necessary to assure compliance with annual reporting requirements

• Must possess relevant knowledge as typically obtained through the completion of a bachelor’s degree in clinical research, compliance or other health-related field
• At least two years of relevant work experience
• Must demonstrate a strong understanding of regulatory affairs, IRB management and/or clinical research coordination/operations with experience work for/with an HRPP and/or IRB in regulatory affairs for clinical research or clinical research coordination/operations
• Ability to effectively and professionally communicate both verbally and in writing with research stakeholders, including physicians
• Must have excellent organizational and task management skills allowing the individual to efficiently multi-task and prioritize workload in a fast-paced environment
• Familiarity with IRB, research compliance and regulations

Demonstrates expertise in regulatory affairs, IRB management, and clinical research coordination, with strong organizational and communication skills to effectively manage submissions and compliance processes.

• Regulatory Affairs
• IRB Management
• Clinical Research Coordination
• Organizational Skills
• Communication Skills

• Research Protocol Review
• IRB Submission Processing
• Compliance Reporting
• Document Development
• Meeting Coordination

• Task Management
• Multi-tasking
• Professional Communication

• Human Research Protection Program
• Research Compliance
• Accreditation Processes

• IRIS