Florida Medical College is open doors to a new beginning enhancing your professional health care title with the Clinical Research Coordinator Certificate. This certification prepare to participants to work in a Clinical Site conducting clinical trials or as Study coordinator aiding in the coordination management and conduct of clinical research under supervision of a designated physician investigator.
This course is suitable for Medical Assistant, Nursing and foreign healthcare professional that include physicians, nurse or other health-care related professionals. Applicant without previous knowledge on medical care may participate after obtain the certification on EKG and Phlebotomy that is a requirement for this course.
Clinical Research Coordinator knowledge will help Medical Assistant to initiate a new future in scientific research and you will be able to work on research places or Clinical Site as part of qualified professionals team to accomplish significant discoveries.
The Clinical Research Coordinator (CRC) course is prepared based on demand of clinical sites and the SOCRA & ACCP the accredited society of Investigation in Clinical Trial. CRC Diploma prepare Medical Assistant to find job related in Clinical Research and Investigation and also allow student to face SOCRA examination when you meet the proper requirements, for Certified Clinical Research Coordinator. International Medical Graduate can apply for this course, although some documents are required
Upon completion this course the attendance should be able to:
. - Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice.
. - Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure.
. - Classify researches and enunciate the phases of clinical trials.
. - Describe components of Site Research.
. - Explain the drug/biologic development process.
. - Outline concepts for Good Clinical Practice (GCP).
. - Describe the device development process.
. - Explain the elements of informed consent.
. - Describe the membership and reporting requirements of IRBs.
. - Explain rules relating to financial disclosure.
. - Discuss the basics of study design.
. - Explain the rules and reporting requirements for adverse events and serious adverse events .
- Definition of Clinical Research Professional
- Good Clinical Practice
- FDA: Federal Regulations, codes, forms and information
- Research Organizations type
- Protection of Human Subjects
- Clinical Safety Data Management
4.1. Attendance: Students are expected to log in, at least, 20 hours per week.
4.2. Exam: One mandatory final exam on computer system with a passing grade will be required to pass this course. Other evaluations will be taken during course.