MAKING INROADS IN INDUSTRY:Contract Research Organizations

IN TODAY'S TECHNOLOGY-DRIVEN economy, a robust range of career options is now available to pharmacists. Prospective job hunters can surf the Internet and quickly realize the variety of employment opportunities that await them. As an example, the American Association of Colleges of Pharmacy Web site, www.aacp.org, provides an ample selection of job choices.¹ From openings in community pharmacies, to institutional work in patient care settings, and consultant positions with government organizations?the choices are as diverse as the individuals within the pharmacy profession.

As in all matters involving an individual?s career management plan, the decision is purely personal. There are no ?right? or ?wrong? answers; but there are certainly some decision drivers that are more (or less) appropriate for each person?s personality, work style, and job environment preferences. While traditional careers may be desirable for a vast number of pharmacists, an appetite for the fast pace and competitive nature of the corporate world can be satisfied through landing a position in industry. The biotechnology industry, which includes pharmaceutical manufacturing and research companies, offers a chance to work and develop in a global marketplace. From large, publicly traded corporate giants that are listed on the major US stock exchanges, to small, privately-held companies with fewer than 500 employees, the biotechnology industry presents a broad horizon of career opportunities.

What is a CRO?

One type of biotechnology company is the contract research organization (CRO). CROs partner with pharmaceutical, diagnostic, and medical device manufacturers to provide the rigorous scientific evidence that demonstrates product safety, efficacy, and value. They conduct clinical research trials around the world, investigating innovative product developments that can benefit patient populations in new or more efficient ways. In addition, CROs will often specialize in certain disease or therapeutic areas, such as analgesia, dermatology, or urology. Within a CRO, some main areas of client service include:

• All aspects of phase 1-4 clinical trial management
• Centralized pharmacy services and clinical supply management
• Medical monitoring and writing
• Regulatory audit
• Patient registries

A recent publication of the American Pharmacists Association indicates that while entry-level salaries may not be as high, the long-term opportunities for growth (in salary and benefits) may be greater in industry-based positions.² Specifically, within the pharmaceutical industry, potential openings for pharmacists might exist in research, clinical supply management, regulatory affairs, medical writing, sales, business development, and executive management. Moreover, it is possible that many of these job types will be available within a single CRO.

Clinical Supply Management

Clinical supply management in the CRO setting involves duties that span a wide range of responsibilities. CRO-affiliated pharmacists may have, as a primary responsibility, the maintenance of a central, on-site clinical supply. Usually located at one of the CRO?s main facilities, this repository houses the clinical supplies for various research trials. From this location, materials are received, stored, and distributed to various clinical trial sites. Used and unused clinical supplies are reconciled and documented. If required, the pharmacist will also dispose of unneeded items. Related duties include interfacing with clinical supply packaging and labeling vendors and the development of drug dosing algorithms for investigational products.

Pharmacists working for a CRO may also become involved in business development activities and staff training opportunities. As an example, a pharmacist?s clinical knowledge may be needed in collaboration with the expertise of other medical professionals to create a research trial protocol. Or, archived drug information may be required by a clinical project team in preparation for a new contract. As business needs arise, pharmacists may be called upon to provide training support in specific therapeutic areas of interest.

In the United States, the FDA requires that certain regulations must guide the conduct of clinical research trials. As a result, CRO-affiliated pharmacists maintain documentation as ordered by the FDA?s mandates. Good Clinical Practices and Good Manufacturing Practices must be followed at all times.³

Increasingly, clinical research trials occur outside US borders. Many CROs maintain offices or facilities abroad for this purpose. In addition, CROs sometimes partner with foreign pharmaceutical companies in the development of new drugs or treatments. Training in specialized clinical supply distribution models may be needed to conduct trials in other countries. Pharmacists who desire a mobile work setting will appreciate the global travel that often accompanies international business relationships.

Finding Work in a CRO

Students who are embarking upon their first pharmacy position should consult trade journals and magazines for recruitment-related advertising and articles about employment in a CRO. Utilizing college and university career services, reading classified employment columns in major newspapers, and networking with peers in both formal and informal settings are useful approaches. Although the paths to finding work with a CRO are very similar to the traditional job search procedures needed to secure any professional, management-level business position, a targeted effort might help. Visit the business reference section of the public library and obtain a list of biotechnology companies, then search those companies? Web sites to view position descriptions and learn more about the industry. Preparation pays, and ultimately, gathering information from multiple sources provides a broader base from which to launch a new and rewarding career.

All authors are with the UBC Late Stage Group, United BioSource Corporation. Dr. Dupre Barnes is a psychologist and writer. Mr. Parks is a registered pharmacist and clinical pharmacy manager. Dr. Chancery is a clinical pharmacist and clinical research associate.

References

1. American Association of Colleges of Pharmacy Web site. www.aacp.org.Accessed October 11, 2005.

2. L.M. Posey. Pharmacy: An Introduction to the Profession. American Pharmacists Association. Washington, DC: 2003;63.

3. The Code of Federal Regulations ? Title 21 Food and Drugs. Media, PA: Barnett Educational Services; 2004.