The Drug Development Cycle is a vast area in which you have many job opportunities. Clinical Research in itself, which is a small part of the drug development cycle, is a field with many options for a life science graduate. Within the limited area of Clinical Research are opportunities lurking at every corner.
What is Clinical Trial/Research?
The studies conducted to evaluate the quality, safety and efficacy of investigational products, be it drugs, biologicals, medical devices or medical procedures on humans in a strictly scientifically controlled setting is termed as Clinical Research.
Here are a few options you can consider –
o Clinical Research Associate (CRA)
o Clinical Research Coordinator (CRC)
o Scientific writer
o Quality Analyst (Quality Assurance and Quality Control)
o Data Manager
o Data Validator
o Data Entry Operator
A CRA mainly deals with administering and monitoring the progress of a Clinical Trial. A CRC, as the name suggests, coordinates the trial at the site. A CRC assists the Investigator in the trial procedures. The Investigator is a person (Doctor) responsible for the conduct of the study at the trial site. Investigator is responsible for the rights, health and welfare of the study subjects.
Scientific writers are the people who prepare documents like the Protocol, which assists in regulatory approvals for the conduct of the trial. Biostatistician is a person who is knowledgeable in the field of mathematics and applies it to the biological systems. The role of a biostatistician in the field of Clinical Research is to analyze the data collected from the trial. Quality Analysts ensure that crystal-method the maintenance of quality throughout the conduct of the trial.
A Data Manager monitors the entire process of data management, right from the entry of data to the final analysis. Data Entry Operator transfers the data on the Case Report Forms to a database for further analysis while a Data Validator is one who ensures that the data collected during a trial is clean and not corrupt in any way.
For the above job profiles, you may be directly employed by pharmaceutical companies or hired by contract research organizations. You may be working for individual data management units or hospitals.
Typically, Investigators, CRAs and CRCs are hired by Contract Research Organizations. Scientific writers and biostatisticians are hired by Pharmaceutical companies while Data Management units hire Validators and Data Entry Operators. Hospitals also hire CRCs.
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