Impact CLINICAL RESEARCH TRAINING academy
PROGRAM OVERVIEW
Are you ready to take your healthcare career to the next level and be a part of the changes and development of medicine? If so, clinical research and medical assisting may be the profession for you. The clinical research/medical assisting training class is a fast-paced, immersive learning course. During the 16 week in-person -boot-camp portion of the class, students spend three hours a day in the classroom, fully engaging with the content that builds their educational & clinical foundation in this field.
- Additional Course Materials and Online Learning
- Clinical Experience/venipuncture/EKG/Vital Signs
- Reading Laboratory Manuals & Processing labs
- Reading, Understanding, & following Protocols & Schedule of Events
- ICH GCP Training & certification
- IATA & C-SSRS TRAINING & certification
- Institutional Review Boards, Informed Consent
- Clinical Trial Initiation
- FDA Forms and Procedures
- Regulatory Documents and Maintenance
- Creating Source Documents
- Investigator and Study Team Responsibilities
- Study Initiation and Close-Out Visits, Compliance and Retention
- Drug Compliance, Storage, and Documentation
- Adverse Events and Safety Monitoring
- Quality Assurance Audits and Monitor Visits
- Preparing for Audits (FDA, Sponsor, & DEA)
Cost for class is $5000.00 includes materials ( Contact us to discuss payment plans)
Clinical Research Audit & Training Services
Impact Clinical Research provides auditing services to ensure that sites are in compliance with the FDA & Sponsors. We ensure all data is of quality work and that the data does not compromise the integrity of the study or participants. There are unique risks to consider at every stage of a clinical trial. That’s why we use a multi-level approach to prepare your team for approval that includes: EVALUATING YOUR SITES AND VENDORS, INSPECTING YOUR FACILITIES, DATA, AND PROCESSES, & PREPARING YOUR STAFF FOR INSPECTIONS, INTERVIEWS, & SITE MONITORING VISITS. We also assist in creating source documents to ensure all data is captured for monitoring reviews.
Benefits of Being Audit Ready
• Assess performance against research requirements
• Ensure the quality and integrity of data collected
• Identify negative process-level trends
• Receive meaningful deliverables about your study, including a summary of findings, an assessment of your greatest strengths, weaknesses and opportunities, and recommendations to achieve compliance
ICR offers convenient, affordable on-site training for teams of all sizes. Our staff brings a broad range of perspectives, with backgrounds ranging from Ob/Gyn to Gastroenterology research. Having a well-trained staff ensures you use a consistent process that meets the most stringent standards of patient safety and compliance. With regulatory inspections on the rise, you need to be sure your site adheres to the most stringent requirements for compliance and patient protection. Our rigorous auditing process is designed to identify and address issues before the FDA finds them and prepare your team to answer questions with confidence.
Clinical Research Coordinator/Medical Assisting Training
$5,000.00
Medical Assisting graduates are equipped to work alongside doctors, nurses, and other medical professionals as an integral part of an industrious health care team. Some work in the front office dealing with patient records and insurance companies. Others may choose to work directly with patients checking vital signs and collecting specimens while providing reassurance and support. The Clinical Research Coordinator (CRC) has a vital role in the conduct of a clinical trial and is a key liaison between the investigator, subject, IRB, and sponsor.
The Research Coordinator (CRC) On-Boarding Program will provide a comprehensive introduction to clinical research and the job functions of the CRC for both drug/biologic and device trials. This program will provide core skills and encourage critical thinking to those individuals looking to support, facilitate, and coordinate the daily activities of clinical trials. Case studies and industry best practices will be presented to underscore how the learning objectives apply directly to the responsibilities of the CRC.