John Gary Email & Phone Number

John Gary Skills

• Excellent written, verbal, and interpersonal communication skills
• AE and SAE reporting
• Adept ability to motivate others
• Adverse Event Reporting
• Attention to detail & data management
• Audit and Inspection Readiness
• Business Relationship Management
• CAPA Implementation
• Chemotherapy
• Clinical Affairs
• Clinical Data Management
• Clinical Development
• Clinical Monitoring Safety Reporting
• Clinical Monitoring protocol deviations and report writing
• Clinical Research
• Clinical Research Experience
• Clinical Trial Management System (CTMS)
• Clinical Trial Monitoring
• Corrective and Preventive Action (CAPA)
• Critical Care Nursing
• Critical Thinking
• Cross-functional Collaborations
• Current trends in drug development
• Data Collection
• Data Entry
• Data Integrity
• Data Reconciliation
• Data analysis & visualization (SQL, Tableau, Power BI)
• EDC Systems (RAVE, VEEVA)
• EDC/CTMS: RAVE, CRIO, EPIC, Cerner
• Effective relationship building skills with trial center staff and colleagues
• Electronic Data Capture (EDC)
• Epic Systems
• Essential documents
• Excellent grasp of numeracy and keen eye for detail
• Excellent time management skills and responsibility prioritization
• Extensive knowledge of medical terminology, anatomy, pathophysiology and pharmaceutical treatment protocols
• FDA & EU Regulatory Affairs
• FDA CFR
• FDA Regulations
• Feasibility Studies
• Good Clinical Practice (GCP)
• Good Clinical Practice (GCP) & Regulatory Compliance
• ICH Guidelines
• ICH-GCP E6 - Good Clinical Practice
• ICH-GCP responsibilities
• IND Submission and approval processes
• IRB/IEC Processes
• Informed Consent Form (ICF)
• Interpersonal Communication
• Leadership
• Maintaining study timelines and budgets
• Microsoft Office
• Microsoft Power BI
• MySQL
• Oncology Clinical Research
• Patient recruitment & screening
• Pharmacovigilance
• Post-approval drug development
• Presentation Skills
• Problem Solving
• Problem-solving and escalation management
• Proficient with MS Word, MS Excel, MS OneNote, and MS Office Suite document management systems
• Protocol Adherence
• Protocol Compliance
• Protocol Deviations
• Public Speaking
• Python (Programming Language)
• Query Resolution
• RealTime
• Regulatory Compliance
• Regulatory Documentation
• Regulatory documentation (IRB, safety reports, CAPA)
• Research Design
• Risk-Based Monitoring
• SOP compliance | Query resolution | SDV
• SQL for Clinical Data
• Sigma Theta Tau
• Site Initiation
• Site Initiation Visit (SIV)
• Site Management
• Source Data Verification (SDV)
• Source data and source data verification
• Stroke Rehabilitation
• Strong attention to electronic data detail and accuracy
• Strong understanding of pharmacology and drug development processes
• Study data ALCOA
• TMF/eTMF
• TMF/eTMF Management
• Teamwork
• Technologies in clinical data management
• Time Management
• Tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution skills.
• Trial site collaboration
• U.S. Health Insurance Portability and Accountability Act (HIPAA)
• Understanding of functioning departments and collaboration between them
• VeeVa Vault (CDMS and CTMS)
• eTMF/ISF Management
• iMetadata RAVE
• Quality Patient Care
• PowerPoint
• Advanced Cardiac Life Support Acls
• Left Ventricular Assistive Device
• Telemetry
• Red Cross Certified
• Cpr Certified
• U.S. Health Insurance Portability And Accountability Act Hipaa
• Hospitals
• Education
• Healthcare
• Outlook
• Medication Administration
• Microsoft Word
• Microsoft Excel
• Basic Life Support Bls
• Certified Nurse Assistant
• Community Outreach
• First Aid
• Customer Service
• Electronic Medical Record Emr
• AED
• Cashiering
• Research
• Childcare
• Cardiopulmonary Resuscitation Cpr
• BLS
• American Heart Association
• Basic Life Support
• Advanced Cardiac Life Support
• Electronic Medical Record
• u.s. Health Insurance Portability and Accountability Act