Clinical Research and Medical Jobs: Pharmaceutical career path

A variety of medical and scientific specialists at pharma companies perform the numerous studies required to take clinical compounds from the lab bench to the pharmacy shelf. Physicians with director or VP titles head up a pharma company's therapeutic divisions and are responsible for ensuring drug safety and for keeping development programs on track. MDs and sometimes PhDs or PharmDs are responsible for drawing up a particular product's overall clinical development plan, which is a strategic and tactical document that lays out the studies a company intends to perform before it applies for marketing approval. They also write or contribute to clinical trial protocols, the instructions for an investigator describing the objectives, design, and methodology of a clinical trial. 

Clinical Trials:

Once the plans are approved by regulatory authorities, clinical research associates (CRAs) take over the nitty-gritty of working with investigators to conduct clinical trials. Depending on the research objectives, these trials may be confined to a small patient group at a single site, or they may involve thousands of patients at hundreds of sites worldwide. Typically RNs, CRAs get involved early on by helping to write study protocols. As a clinical trial proceeds, they meet with investigators and their staff to ensure that the study protocol is being followed, and they also monitor the collection of patient data. 

One thing to note: Many pharmaceutical companies outsource the conduct of some or all of their clinical trials to companies called contract research organizations (CROs). If you work in clinical development within Big Pharma, interacting with CROs will be an important part of your job. Likewise, if you're an MD, PhD, MS, RN, or PharmD interested in working in clinical development, you may find that CROs offer engaging and rewarding career opportunities similar to those offered within Big Pharma companies. 

Clinical Development:

Clinical development offers other career options, too. Regulatory affairs experts (typically scientists at the master's or PhD level, or with public health training) are the liaisons between industry and government. Most companies divide regulatory affairs into two divisions-one that deals with clinical development, and another devoted to the composition and quality of the pharmaceutical products. Both divisions communicate directly with government regulatory bodies and manage great volumes of paperwork.

Clinical Research Physician:

Clinical Research Physicians (CRPs) are MDs who develop and implement plans for ushering experimental drugs through preapproval clinical trials. They work on cross-functional teams to maximize understanding of the pharmacological, regulatory, and clinical dimensions of the drugs being studied.

Clinical Research Associate:

 These are the folks who oversee clinical trials. They get involved in designing protocols, enlisting physician investigators, training clinic personnel, and evaluating data. The job can require travel, sometimes as much as 80 percent of the time, but it doesn't always. CRAs may also manage the services of an independent clinical research organization that runs the actual studies. A BS, BSN, or RN is required.