Our Training

We provide an accelerated training program to help you achieve clinical trial foundation in as little s 8 weeks to start your career. Courses are designed for persons that have or do not have clinical research experience, that are seeking qualifications and/or current practical knowledge to effectively work to develop exciting new therapeutics to work for biotechnology, pharmaceutical and medical device industries.

The Training Goals of Course

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To provide a thorough review of the good clinical practices (GCP), ICH, FDA/TPD regulations, roles, and responsibilities of the Clinical Research Associate/Monitor (CRA), Clinical Trial Associate (CTA) or Clinical Trial Manager (CTM)
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To provide graduates with the key skills, job criteria and industry expectations for the positions of Clinical Research Associate/Monitor (CRA), Clinical Trial Associate (CTA) or the Clinical Trial Manager (CDM).
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To provide the necessary Job Placement Assistance to allow graduates to get hired in an entry-level or senior-level position soon after completion of the training program.

Simulation Exercises:

Students will participate in many online simulation exercises during the training program that will expose you to actual monitoring situations such as Investigator Selection, IRB Approval, CRF Review, SDV, Good Clinical Practice and Drug Accountability and Adverse Event assessment.

Target Groups

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Nurses, Clinical Research Coordinators, Clinical Research Associates
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Physicians, Dentists, Physician Assistants, Medical Monitors, Statisticians
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Pharmacists, Pharmacologists, Database specialists, Principal Investigators
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Medical Technologists, Laboratory Technicians, Biostatisticians
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Physical Therapists, Respiratory Therapists, Psychologists
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Biologists, Chemists, Medical Writers, Clinical Data Managers
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Microbiologists, Biochemists, QC Analysts, other life-science professionals

The Training Goals of Course

At the end of course, students will be able to:

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Analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
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Make certain that the scientific integrity of the data collected is protected and verified.
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Review all case report forms and compare them to source documents.
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Understand the drug development process and roles/opportunities in Clinical Research.
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Identify ethical issues in clinical research and their impact on the development of new products.
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Understand the latest Good Clinical Practices.
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Identify adverse effects and proper reporting format.
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Appreciate the types of sponsor-investigator site visits.
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Institute and obtain proper Informed Consent.
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Know the primary roles and responsibilities of their role.
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Monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
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Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
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Assure that adverse events are correctly documented and reported.
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Learn to employ efficient subject recruitment methods.
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Develop a suitable clinical trial protocol and suitable study budget.
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Assure the protection of the rights, safety and well being of human study subjects.
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