Thursday, July 12, 2012

June 2011 Newsletter for Research Professionals

The Newsletter for Research Professionals:     
june 2011
Clinical research is ostensibly the most lucrative and potentially interesting field of research for those with health care or science credentials. That is in part because these jobs are often backed by large pharmaceutical companies who have the resources to provide researchers with all the latest technology and equipment. The feel good component is there in clinical research as well, because more often than not a clinical researcher is involved in trials which result in medical advances to cure or alleviate suffering. Consequently these positions are highly sought after and often require some additional accreditation. Despite the desirability of the position demand for clinical researchers remains high with over 500 postings in the field available now at throughout America and the world.

Clinical research: CRA
CRA is the acronym for Clinical Research Associate a position which may also be referred to as a Clinical Monitor. This position is the crème de la crème of clinical research because the CRA has the authority to oversee clinical projects and is a key player in the establishment of research direction. As such extra credentials are required of a CRA. Once these are acquired a CRA may work within a medical lab, doctor’s office, hospital or clinic. They will be assigned a project(s) and they are ultimately responsible for project integrity in terms of data collection, patient well being and research methodology. But again, there are over 150 job postings specifically for CRAs available online right now. So although the job is highly sought there is here, as in most clinical research fields today, greater demand for CRAs than there are applicants to fill the jobs available.
The research process of a clinical researcher is often one in which a company or health provider is attempting to prove the safety and efficacy of a product or procedure in preparation for FDA approval. These studies require meticulous documentation and rigorous compliance with safety standards. There is a significant process and standard that must be proved before any new product or procedure will be accepted by appropriate boards which may include the FDA, the IND, the IDE, IRB or IDE or all or some of these combined. So the clinical researcher has a massive responsibility. In exchange the job offers diversity, crossover and good money. Statistics from the US Bureau of Labor Statistics shows:
Median annual wages of medical scientists, were $72,590 in May 2008. The middle 50 percent of these workers earned between $51,640 and $101,290. The lowest 10 percent earned less than $39,870, and the highest 10 percent earned more than $134,770. Median annual wages in the industries employing the largest numbers of medical scientists were:
Drugs and druggists' sundries merchant wholesalers
Pharmaceutical and medicine manufacturing
Scientific research and development services
General medical and surgical hospitals
Colleges, universities, and professional schools
Earnings are lower and benefits limited for medical scientists in postdoctoral placements; workers in permanent positions typically receive higher wages and excellent benefits, in addition to job security.

"It is ironic that in the same year we celebrate the 50th anniversary of the discovery of DNA, some would have us ban certain forms of DNA medical research. Restricting medical research has very real human consequences, measured in loss of life and tremendous suffering for patients and their families."

Michael J. Fox

Phases in human clinical trials

Once clinical trials have been through the pre and post animal testing stages (if any) they are finally ready for testing with humans. Every country regulates how this testing must occur and but almost all will consistently require that the testing is undertaken in phases with healthy humans initially.

Phase 1 trials

This phase involves investigating the drug or treatment amongst a small number of research subjects who are healthy volunteers. This phase is targeted at identifying the safety, tolerability, and the general mechanism of the action of the drug in humans. These studies are normally carried out in tightly controlled environments and participants receive 24-hour medical attention and monitoring.

Phase 2 trials

Phase 2 attempts to understand a drug's safety and efficacy at varying dosages; finding out the right dose to be effective while staying within risk parameters. This phase will require more than 100 patients to demonstrate relevant results, although the actual number of subjects varies widely based on the disease under study. During this phase the trial may continue to use healthy subjects or may use subjects with a specific illness.

Phase 3 trials

Once the drug is proved reasonably safe and effective on a limited number of people the 3rd phase broadens the subject base and exposes more than 1000 research subjects at multiple locations. There is now a concerted effort to establish safety and effectiveness upon a variety of demographic and socioeconomic subjects. A comparison is usually made with standard drugs available on the market. It is imperative that the drug is shown to be effective and safe in this phase to receive NDA approval, or it will not reach phase 4.

Phase 4 trials

In phase 4, the goal is to identify unknown adverse reactions and to research new therapeutic indications. Companies often use this phase to provide exposure to different physicians and clinics, which helps to market the future product.

"Science cannot resolve moral conflicts, but it can help to more accurately frame the debates around these conflicts."
Heinz R. Pagels

tHIS month’s NUMERO UNO job interview TIP:

Important information for job seekers wanting to work in clinical research:
There are more jobs available in clinical research than there are qualified researchers. That means job applicants are competing in a less competitive field than other researchers; for instance market researchers. That is the good news. The flip side is that the importance of this research is such that employers are keen to hire proven talent with meticulous track records. That means that job applicants to these positions must really pull out all the stops and be organized in terms of evidence of all relevant credentials, extra certification and both personal and professional references. For those who have taken the time to gain CRA accreditation the job opportunities are unlimited.
While CRA certification may give you an edge over other job seekers it isn’t necessarily required for the position. Typically these jobs will go to nurses, medical technologists and therapists but any science degree will provide the basic requirement of a CRA. Employers will often look for people skills as well as academic credentials when hiring for these positions. The CRA must be able to manage other researchers as well as provide the caring and relaxed environment required to keep human volunteers/trial subjects happy.

"When burned on a CD, the human genome is smaller than Microsoft Office."
Steve Jurvetson

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