Clinical Trial Support and Training since 2016
Medical and Technical Writing
Medical and Technical Writing
Medical and Technical Writing
- Protocol development
- Standard operating procedures (SOPs)
- Clinical study reports (CSRs)
- Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) literature searches and reviews
- Boolean literature searches
- Statistical analysis plans (SAPs)
- Clinical evaluation reports (CERs)
- Training and investigator meeting presentations
- Abstrac
- Protocol development
- Standard operating procedures (SOPs)
- Clinical study reports (CSRs)
- Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) literature searches and reviews
- Boolean literature searches
- Statistical analysis plans (SAPs)
- Clinical evaluation reports (CERs)
- Training and investigator meeting presentations
- Abstracts and manuscripts
- Clinical marketing materials
- Operational plans, templates and forms
- Excel and Smartsheet clinical tracking development
- Data analysis and interpretations
Clinical Operations
Medical and Technical Writing
Medical and Technical Writing
- Clinical quality and strategy consulting
- Clinical operations support
- Project and trial management
- Site selection and qualification
- Site initiation and training
- Site management
- Case report form (CRF) and Trial master file (TMF) review
- Risk-based monitoring (RBM)
- Source document verification (SDV)
- Data line listing audits and trend analysis
- Clinical
- Clinical quality and strategy consulting
- Clinical operations support
- Project and trial management
- Site selection and qualification
- Site initiation and training
- Site management
- Case report form (CRF) and Trial master file (TMF) review
- Risk-based monitoring (RBM)
- Source document verification (SDV)
- Data line listing audits and trend analysis
- Clinical quality audits
- Gap assessment
- Corrective and preventative action (CAPA) planning and documentation
- Basic statistical analyses
- Clinical trial management system (CTMS) and eCRF database systems including Medidata Rave, Oracle Inform, IBM Merge, DataFax, and more.
Coaching/ Training
Medical and Technical Writing
Coaching/ Training
- Good Clinical Practice (GCP)
- Good Documentation Practice (GDP)
- Clinical Research Associate (CRA) mentoring
- Clinical Research Coordinator (CRC) training
- Responsibility matrix development including RACI (responsible, accountable, consulted, and informed)
- Public speaking and presentations
- Clear and concise technical communication
- Effective meeting
- Good Clinical Practice (GCP)
- Good Documentation Practice (GDP)
- Clinical Research Associate (CRA) mentoring
- Clinical Research Coordinator (CRC) training
- Responsibility matrix development including RACI (responsible, accountable, consulted, and informed)
- Public speaking and presentations
- Clear and concise technical communication
- Effective meetings and minutes
- Email efficiency and etiquette
- Audit preparation
- Career development
Specializing in
Ophthalmology, Neurology and Stroke
Experience also includes Acute Ischemic Stroke, Adhesions, Cardiology, Colon Cancer, Endocrinology, Endometriosis, Epilepsy, Family Planning, Gastroenterology, General Surgery, Hemophilia, Hysterectomy, IBD, Incontinence, Infertility, Laparoscopy, Laparotomy, Laser Vision Correction, Large Vessel Occlusion, LASIK, Menopause, Neurovascular, Osteopenia, Osteoporosis, Pregnancy, Peripheral Vascular Disease, Presbyopia, PRK, Refractive Surgery, Reproductive Health, Stroke, Thrombectomy, Vascular Disease, Women’s Health.