Training Goals To provide a thorough review of the good clinical practices (GCP), ICH, FDA/TPD regulations, roles, and responsibilities of the Clinical Research Associate/Monitor, Coordinator or Data Manager. To provide graduates with the key skills, job criteria and industry expectations for the positions of Clinical Research Associate/Monitor, Coordinator or Data Manager. 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.

Practical Hands-on Experience You will be allowed to participate in many simulations during the training program that will give you  "hands on experience" in actual monitoring situations such as Investigator Selection, IRB Approval, CRF Review, SDV, Good Clinical Practice and Drug Accountability and Adverse Event assessment. Training Objectives         Upon completion of this program, 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 documents. Know the primary roles and responsibilities of the Clinical Research Associate (CRA), Clinical Data Manager (CDM) and Clinical Research Coordinator (CRC). Understand the drug development process and roles/opportunities in Clinical Research. Identify ethical issues in clinical research and their impact on the development of new products. Institute and obtain proper Informed Consent. Understand the latest Good Clinical Practices. Learn to employ efficient subject recruitment methods. Develop a suitable clinical trial protocol and suitable study budget. Identify adverse effects and proper reporting format. Appreciate the types of sponsor-investigator site visits Develop qualifications sought by the Pharmaceutical, Biotech & Medical Device industry.  Target Groups Nurses, Clinical Research Coordinators, Clinical Research Associates, Clinical Data Associates/Managers  Physicians, Dentists, Physician Assistants, Medical Monitors, Statisticians, Biostatisticians Pharmacists, Pharmacologists Medical Technologists, Laboratory Technicians Physical Therapists, Respiratory Therapists, Psychologists Biologists, Chemists, Medical Writers.  Training Duration Average completion time - 2 to 3 months studying part-time Actual completion time varies depending on your pace of study  Training Costs Tuition fee - $1,650.00 (US funds) Course Materials - FREE   Industry Demand for CRAs, CDMs and CRCs  Our Alumni have either found employment with or have been referred from a wide cross-section of hospitals, clinics, CROs, biotech and pharmaceutical companies across North America and globally. With the knowledge and job skills gained as a result of your study, you can help to meet the ever-growing demand for trained CRAs, CDMs or CRCs to develop exciting new therapeutics for the 21st century in the biotechnology, pharmaceutical and medical device industries.     Most Recent Unsolicited Testimonials: From: Ben xxxxxxxxx <benxxxx@yahoo.com> To: Online Instructor <onlineinstructor@crtinstitute.org> Sent: Tue, March 15, 2011 1:04:21 AM Subject: CRA training program completed by Ben xxxxxxxxx 03/15/2011   CRA training program completed by Ben xxxxxxxxx 03/15/2011 Dear. Dr. Samuel Longmore Course Instructor, CRA Institute Please accept my thanks for the opportunity to complete the CRA Training, for sharing with me all this valuable information, and for your readiness to assist us students during this period. Best regards, Ben xxxxxxxxx From: Rhesa xxxxx <rhexxxx@yahoo.com> To: onlineinstructor@crtinstitute.org Sent: Thu, February 3, 2011 3:44:25 AM Subject: An advise of Completed CRA Training Program   To: Dr. Samuel Longmore Course Instructor The CRA Institute Greetings!!! I'm gladly to inform you that I have already submitted all the answers to every module in the CRA Training Program and it means that I have completed the program. Thank you so much sir for guiding me (us) by having time reading all the answers and providing the module necessary for the said course. Have a great day ahead! Respectfully yours, Rhesa xxxxxxx, M.D. Philippines     From: "xxxxxxx, Kristina" <slxxxxrk@umich.edu> To: "onlineinstructor@crtinstitute.org" <onlineinstructor@crtinstitute.org> Cc: "xxxxxxx, Kristina" <sxxxxxk@umich.edu> Sent: Tue, December 21, 2010 8:43:40 PM Subject: Course Completed...   Greetings~ Thank you for substantive material and challenging exercises.  Please advise on when a certificate of completion will be provided to me, so that I may report this to my director at the University of Michigan. Thank you! Kristina xxxxxx _________________________________________________________________________________________ From: "xxxxxxx, Kristina" <slxxxxrk@umich.edu> To: "onlineinstructor@crtinstitute.org" <onlineinstructor@crtinstitute.org> Sent: Wed, August 18, 2010 7:58:41 PM Subject: Module 2b - Assignment Good Evening! I enjoyed this segment! My assignment is attached. Thank you, Kristina Xxxxxxxx __________________________________________________________________________________________ From: "stephanie.xxxxxxx@emdchemicals.com" <stephanie.xxxxxxx@emdchemicals.com> To: admin@crtinstitute.org Sent: Mon, July 26, 2010 5:52:51 PM Subject: Fw: Completion of training program The training course was great - it was nice to be able to complete it at my own pace.  In addition, I've already landed a job as a CRA! Thanks, Stephanie xxxxxxx QC Scientist   ________________________________________________________________________________________________________________________ From: mary xxxxxxx <maryxxxxxxxxx@sbcglobal.net> To: info@crtinstitute.org Sent: Sat, June 26, 2010 4:38:41 PM Subject:   I have finished the course.  I have updated my resume based on your recommendations.  I have a job with a CRO which I just started last week.  Thank you for your assistance.  Mary xx xxxxxxx RN MSN _______________________________________________________________________________________________________   Click to enroll and start studying!