The CRA(s) in accordance with the sponsor’s ( the pharma company) requirements should ensure that the trial is conducted and documented properly by carrying out the necessary activities when relevant and necessary to the trial and the trial site.
CRA acts as the main line of communication between the sponsor and the investigator site. ( Hospital)
CRA Verifies that the investigator has adequate qualifications and resources and remain adequate throughout the trial period, facilities, including laboratories, equipment, and staff, is adequate to safely and properly conduct the trial and remain adequate throughout the trial period.
Sunday, October 11, 2009
CLINICAL RESEARCH ASSOCIATE (CRA)
Wednesday, October 7, 2009
Pharmacovigilance (PV) or drug safety
Pharmacovigilance (PV) or drug safety is the pharmacological science relating to the detection, assessment, understanding and prevention adverse reactions, particularly long term and short term side effects of medicines.
Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products
Clinical research & Clinical trials
Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease
Questions & Answers
Let me explain in Q & A format.
H1 B (specialty worker).
What will the compensation or annual CTC (salary)?
Depends on the experience and ranges from 80-140k annually. You will be working in pharmaceuticals companies,
What other skills do you need to have to qualify for this drug safety associate position?
Apart from your Clinical knowledge, you need to know about ICH guidelines and FDA rules.
Feel free to reach me at kumarqtech@gmail.com, i will answers your queries.
Good Luck in your future endeavors