OrthoCarolina Research Institute (OCRI)
Research Services
I. Research Study Management (FDA Clinical Trials & Outcome Studies)
- Pre-site selection visits/surveys
- Site initiation visits
- Study coordination
- Regulatory submission
- Institutional Review Board (IRB) (21 CFR Part 56)
- Informed Consent Form (ICF) (21 CFR Part 50)
- Protocol Amendments
- Final Investigational Device Exemption (IDE) Safety Reports
- Serious Adverse Events (SAEs)/Adverse Events (AEs)
- Financial Disclosures (21 CFR Part 54)
- Protocol Deviations
- Attend IRB meeting
- Budget development and negotiations
- Contract/Clinical Trial Agreement (CTA) with sponsor, Institute attorney, and hospital
- Interactions with Clinical Research Organizations (CROs), Monitors, Sponsors, Medical Directors
- Hospital Staff In-Service
- Pharmacy Order sets
- Patient interaction
- Schedules
- Follow-up
- Questionnaires/Surveys
- Lab work (e.g., blood draws, urine samples, processing and shipping specimen, etc)
- Study Procedures
- Case Report Form (CRF)/Source document completion
- Internal audits
- Drug and device accountability
- Compliance with all FDA regulations
- Study closeout
- Record retention and safe storage
- Final queries and reports (IRB and sponsor)
- Coordinator training
- Good Clinical Practices (GCP)
- Saf-T-Pak (Infectious Substance and Diagnostic Specimen Packaging and Compliance Training)
- Research Training Modules
- Investigator Training
- Assist Fellows and Residents with study design/implementation
II. Basic Science Projects
- Management and facilitate
- Institutional Animal Care and Use Committee (IACUC)
- Protocol preparation and submissions
- Documented literature searches
- Justification for animal usage
III. Study Design
- Protocol development
- Hypotheses
- Study objectives
- Study End points
- Sample size estimate
- Time line
- Methods
- Statistical analysis plan (SAP)
- CRF/Source Document design
- Data Management
- Database design
- Data entry
- Quality control
IV. Data Management
- Database design
- Queries (MegaWest, IDX, and AS400)
- Chart/Radiographic review
- Data entry
- Statistical Analysis
- Generate Figures/Tables
- Sample size estimate/power analysis
- Survivorship Analysis
V. Presentations
- Abstracts
- Posters
- PowerPoint
VI. Publications (Manuscripts/ Book Chapters)
- Medical writing
- Editing
- Format to journal guidelines
- Submissions to journals (online)
- Tracking status of manuscript
- Journal review, edits, revisions
- Galley proofs
VII. Administrative
- Board of Director Meetings – Bi-annually
- Patient education (non-study related)
- Legal
- Institute compliance (Clinical Trial Agreements)
- Accounting
- Individual Study finances
- Research Institute finances
- Budget planning
- Annual audits
- Research Advisory Committee (RAC) Meetings - Quarterly
- Personnel recruitment
- Staff
- Continuing Education
- Evaluations
- Salaries/Raises
- Maintain interactions with other professional groups
- Presbyterian Hospital System
- Carolinas HealthCare System (CHS)
- University of North Carolina at Charlotte (UNCC)
- Departments of Bioengineering, Health/Human Services, Kinesiology
- Cannon Research
- Dickson Health Institute
- Greater Charlotte Association of Clinical Research Professionals (GCACRP)
VIII. Funding
- Grant Writing
- Capital Campaign
- Special Event Funding
- Corporate Study Funding
IX. Community Outreach
- Oscar Miller Day
- The Joint Celebration
- Explorer’s Program
X. Miscellaneous
- Literature searches/Journal articles
- Digital photography
- Scanning