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CLINICAL RESEARCH TRAINING

We also provide high class Clinical Research Training. We promise that our specialized training will reduce the time to active work and will prepare each individual to challenge higher tasks. We can customize our training to your operating model. Our Industry experienced staff will train each candidate on any level.

A Clinical Research Associate, also known as a Monitor, is an individual that oversees the progress and conduct of a clinical trial. A clinical trial is usually implemented by physicians at a hospital, clinic or physician’s office. The CRA is required to oversee the initiation, progress, the conduct of the clinical trial to ensure the scientific integrity of the data collected, the protection of the rights, safety, and well-being of human study subjects.

The CRAs frequently has a health care or science background (e.g. nurse, medical technologist, or physical therapist; or Bachelor’s, Masters, or a Ph.D. in a science). The CRA is usually employed by a pharmaceutical company, contract research organization, academic institution, or site management organization. A CRA can work either in-house or in the field, requiring 50-70% travel. A field monitor will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial.

Pharmaceutical companies are presently seeking to reduce the development time necessary for their products to receive FDA approval for marketing. Monitoring of a clinical trial is the first mechanism in identifying potential data discrepancies and regulatory issues. Inadequate monitoring can jeopardize the safety of the study participant and/or is a leading contributor to the delay in gaining drug approval. A well-trained and knowledgeable CRA plays a vital role in protecting the study participant and helping to reduce the time between drug development and marketing approval. The demand for knowledgeable and trained CRAs continues to grow however the supply is limited.

Curriculum

  • Fundamental of Clinical Research
  • Basics of Drug Development
  • Translation Research
  • ICH GCP/ FDA guidelines
  • Project Management Skills/Tools
  • Clinical Trial Monitoring
  • Clinical Trial Management
  • Demo EDC, CTMS and ETMF systems
  • Literature search and Medical writing
  • Biostatistics
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Exclusive CRA Training

We also train qualified candidates such as RN, Pharm D, PhD and other science graduates to equip them with all tools required to enter the Clinical Research Industry.