1. Clinical Research Associate (CRA) / Clinical Monitor
2. Clinical Logistics Manager (CLM)
3. Clinical Data Manager (CDM)
4. Medical Research Associate (MRA) / Drug Safety Associate
1. Clinical Research Associate (CRA)
The terms Clinical Research Associate (CRA) and Clinical Monitor (abbr. Monitor) are often used as synonyms. Although there are actually some differences in the duties, these often depend on the company, employer or project. Most often, the term CRA is used, as can be seen in most job offers.
Since a CRA/Monitor is not a conventionally recognized profession with standard training and qualification, there is no official job description.
Over 60% of CRAs are women.
The work of a CRA:
Most CRAs work either for Contract Research Organizations or in the research section of pharmaceutical companies.
The CRA is part of a team which is responsible for the organization and conduct of clinical trials and acts as the link between the investigator and the trial sponsor.
The main tasks of a CRA include supporting investigators, validating collected study data and ensuring that all parties comply with the prevailing guidelines and regulations.
CRAs can expect to spend 50-70% of their working time travelling; the remaining time is needed for the preparation and processing of visits and the report writing and compiling essential documentation.
A visit to a study centre normally takes several hours, occasionally even several days. During trials, study centers are visited periodically by the CRA over a period of months, sometimes even over years.
2. Clinical Logistics Manager (CLM)
Clinical trials require a wide variety of supplies: in addition to the trial drug, diagnostic and testing equipment, refrigerators, centrifuges, ECG machines, every site must also be supplied with numerous trial documents. Their timely and cost-effective delivery is central to the smooth running of a trial.
The work of a CLM includes:
• calculating drug supply requirements and timing;
• coordinating drug production on behalf of the sponsor;
• determining labeling requirements;
• shipping products to warehouses, depots, and trial sites;
• tracking shipments;
• dealing with import/export requirements;
• maintaining inventory levels;
• managing lab data.
3. Clinical Data Manager (CDM)
The data collected by CRAs from trial sites is entered into databases. With the help of computer-based systems, the Clinical Data Manager runs discrepancy checks and validates the data, which is then coded according to WHO standards and prepared for statistical processing.
A Clinical Data Manager is largely computer-based. A CDM needs to have an eye for detail and to understand the medical significance of data.
4. Medical Research Associate (MRA) / Drug Safety Associate
A Medical Research Associate is responsible for the handling of serious adverse events in clinical trials. An MRA composes reports and processes notification forms for the relevant authorities in accordance with local legal requirements:
The work of an MRA includes:
• evaluating and interpreting serious adverse events
• conducting scientific analyses of drug risks
• understanding the causalities and estimating the seriousness of side effects
• conducting risk-benefit analyses of drugs already on the market
• advising on aspects of pharmacovigilance in clinical trials
• optimizing drug safety processes
• compiling information material for doctors, pharmacists and patients