Clinical Research Specialist

Today the pharmaceutical market shows steady growth in demand for clinical research specialists (clinical monitors). This is driven by the growth of CROs in Russia and the CIS, and by pharmaceutical companies’ own interest in running trials in the region.

According to experts, this interest is linked to: a strong research base, relatively low cost of trial setup, a large pool of patients willing to test an investigational drug and the lowest dropout rates. Another important factor affecting the number of trials in Russia is the state control over drug quality and safety. Clinical trials are run to prove the efficacy and safety of drugs in development or on the market. To register a drug on the Russian market the results of preclinical and clinical studies must be submitted to the federal drug-quality authority. Foreign clinical-trial results are not always accepted in Russia as sufficient.

Clinical research specialists are responsible for conducting trials in Russia — and sometimes in CIS countries — in accordance with GCP (Good Clinical Practice) as set out in industry standards OST 42-511-99 and OST 91500.14.0001-2002 (clinical-economic study).

Specific duties of clinical monitors are defined in job descriptions, SOPs and the Monitoring Plan prepared for each project. They include running clinical trial programs, developing the study plan, selecting sites, regular site monitoring, checking documentation completed by investigators, collecting and analyzing results.

Medical departments of pharma companies and CROs want a monitor with a higher-education degree (medical, pharmacy or biochemistry), English-language proficiency and experience participating in clinical trials. Candidates need an analytical mindset and an aptitude for scientific and organizational work. Willingness to travel is very important — research sites are spread across Russia.

In the pharma job market the clinical-monitor role is an attractive starting position for many specialists. Motivators for most candidates are the profession’s prospects, proximity to the scientific field and compensation. Entry-level salaries for clinical monitors start around $800–1,200.

In the Moscow region the profile of such a specialist looks as follows:

Candidates for clinical-research specialist positions have higher education from leading universities. Most come from I.M. Sechenov Moscow Medical Academy (MMA) or N.I. Pirogov Russian State Medical University (RGMU) (see Fig. 1). Most are physicians; pharmacists are a much smaller share (Fig. 2).

Physicians are also trained by Lomonosov Moscow State University Faculty of Fundamental Medicine, Moscow State University of Medicine and Dentistry and RUDN. Graduates of the Moscow State Academy of Veterinary Medicine and Biotechnology are also interested in the clinical-monitor vacancy — mainly biology-faculty graduates.

Among non-Moscow universities, Smolensk State Medical Academy and St. Petersburg medical universities are most represented, though such specialists often complete postgraduate studies in Moscow.

Fig. 1

Fig. 2

As Fig. 2 shows, most candidates are physicians by training (76%).

The specializations of physicians who turn to clinical monitoring can vary widely (Fig. 3), but the most common among CRAs are general practitioners (20%), cardiologists (16%), dermatovenerologists (9%) and psychiatrists (8%).

Fig. 3

More than half of CRA candidates (52%) hold a candidate-of-sciences degree, and 9% are already doctors of sciences. 4% are still in postgraduate studies preparing to defend. The rest have no academic degree, though about 2% completed postgraduate studies without a dissertation defense.

37% of applicants have additional education. Fig. 4 shows the types — business training (sales, presentation, negotiation) leads. GCP certification is second.

A GCP certificate is important but not mandatory. 75% of future clinical monitors apply GCP in practice without holding the certificate.

Fig. 4

This is because more than half of those seeking pharma or CRO jobs already have direct clinical-trial experience. 60% of applicants have scientific-research experience; two-thirds of those worked as investigators or co-investigators in various trial phases. They understand the process from the inside.

Unfortunately the remaining quarter of candidates for the clinical-monitor vacancy do not have a strong grasp of these rules.

Often a CRA vacancy requires at least some (from 6 months) experience in the pharmaceutical business. About half of applicants already have it. The standard career start is as a medical representative, and 16% have come through that step. There are also specialists who moved from research and clinical work into medical-advisor or product-manager roles — usually with experience organizing clinical trials on the sponsor side.

As noted above, employers want candidates with English. 15% of applicants speak no foreign languages at all; about the same share (16%) can work with documents and professional literature in English but cannot converse or correspond in it. The rest claim English proficiency, though not all are truly fluent. Some candidates have additional working languages — German, and less frequently French or Italian.

Summarizing the portrait, a successful CRA candidate should:

1. obtain a medical or biological degree from one of the leading specialized universities;
2. have experience in practical medicine or research;
3. be fluent in English (knowing one more language is a plus, but French, German and Chinese combined will not compensate for lack of English);
4. have experience participating in clinical trials.

All candidates should also realize that in companies the clinical-research-specialist role is in fact a rank-and-file position — and be prepared for that despite their academic degree or professional reputation.