Different early level positions/Designations in Clinical Trials

• All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
• Benefits outweigh risks for each patient.
• Rights, safety, and well-being of patients prevail over science.
• All available non-clinical and clinical information on any investigational agent can support the trial as designed.
• All data is scientifically sound and clearly described.
• Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
• Everyone involved in the clinical trial is qualified by training, education and experience.
• All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
• Confidentiality of subjects is respected and protected.
• Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
• Systems to ensure quality are implemented in all aspects of the trial.

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI).

• All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
• Benefits outweigh risks for each patient.
• Rights, safety, and well-being of patients prevail over science.
• All available non-clinical and clinical information on any investigational agent can support the trial as designed.
• All data is scientifically sound and clearly described.
• Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
• Everyone involved in the clinical trial is qualified by training, education and experience.
• All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
• Confidentiality of subjects is respected and protected.
• Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
• Systems to ensure quality are implemented in all aspects of the trial.