Our Accredited Interactive-online Clinical Research Professional Certification Courses are designed for persons with or without prior on-site clinical trials experience, seeking qualifications and/or current practical knowledge to effectively work as a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Data Coordinator or Clinical Data Manager (CDM) in the monitoring of clinical trials globally in all countries that follow the ICH-GCP guidelines for conducting clinical trials.
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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 Research Coordinator (CRC) or Clinical Data Manager (CDM).
- To provide graduates with the key skills, job criteria and industry expectations for the positions of Clinical Research Associate/Monitor (CRA), Clinical Research Coordinator (CRC) or...more
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...more.
Upon completion of each course, participants will be able to:
- 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.
- Assure the protection of the rights, safety and well being of human study subjects.
- Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
- Monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
- Make certain that the scientific integrity of the data collected is protected and verified.
- Assure that adverse events are correctly documented and reported.
- Review all case report forms and compare them to source...more