Research Laboratory Learning Objectives
• To acquire the skills necessary to perform research at an FDA regulated environment
• To acquire the skills to maintain a Cleanroom compliant according to USP 797
• To gain a basic understanding of Stem Cell Cryopreservation, Stem Cell culture, Flow Cytometry, Multiplex (ELISA) and Fluorescent Inverted Microscopy
• To assist with ongoing research projects in the laboratory
• To understand Good Clinical Practices and how to maintain compliance
• To learn HIPAA Compliant patient care practice
• To understand the processes and procedures of clinical research in an orthopedic setting
• To acquire the skills necessary to perform and oversee proper informed consent process
• To understand the documentation process before, during, and after a clinical research trial
• To obtain patient care experience
• To learn how to navigate and utilize electronic data capture systems
• To enhance skills related to patient care and interactions
General Learning Objectives
• To gain experience working in a professional healthcare laboratory setting
• To obtain or enhance sports medicine knowledge
• To enhance the understanding of Microsoft Excel, Word, and Power Point
Overview of Responsibilities & Expectations
• Assist Clinical Research Coordinators (CRC) in any procedures or patient visits as needed
• Assist CRC in scheduling patient visits
• Gather patient adverse events and concomitant medications at each visit
• Administering patient questionnaires
• Assist CRC in informed consent process
• Support CRC in obtaining progress notes by scribing the patient visits
• Enter patient visit data into electronic data capture system
• File and fax study records as necessary
• Support Director of Quality during sample analysis
• Interact professionally and respectfully with research participants, upholding participant privacy and ethics in accordance with IRB and HIPAA regulations
• Perform literature searches needed for new project development and manuscript preparation
Time Commitment (Days/Hours)
• Recommended 2 consistent days per week for 6-7 hours each day.
