Online Clinical Research Associate Training Course
Total Continuing Education Credits (CEUs) - 250 hours
- 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 the Clinical Data Manager (CDM).
- 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.
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.
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 documents.
- Know the primary roles and responsibilities of the Clinical Research Associate (CRA), and Clinical Research Coordinator (CRC), or Clinical Data Manager (CDM).
- 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.
- Nurses, Clinical Research Coordinators, Clinical Research Associates
- Physicians, Dentists, Physician Assistants, Medical Monitors, Statisticians
- Pharmacists, Pharmacologists, Database specialists, Principal Investigators
- Medical Technologists, Laboratory Technicians, Biostatisticians
- Physical Therapists, Respiratory Therapists, Psychologists
- Biologists, Chemists, Medical Writers, Clinical Data Managers.
- Microbiologists, Biochemists, QC Analysts, other life-science professionals
- 100% Online, Self-Paced Training, Start Anytime.
- Average completion time - 2 to 3 months studying part-time (250 Hours)
- Actual completion time varies depending on your pace of study
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, CRCs or CDMs to develop exciting new therapeutics for the 21st century in the biotechnology, pharmaceutical and medical device industries.