Management Training

As mentioned in the last issue of ALN® Magazine, career opportunities are the next focus of our journey into the world of pre-clinical contract research organizations (CROs). Many people find CRO work extremely gratifying and challenging. Great personal satisfaction can come from helping a new medical device, drug, vaccine, or other medical product be approved for use in humans or animals. Many employees of CROs worldwide feed on this type of satisfaction. The variety of work and ability to be trained in many different operational and technical areas also motivates workers.

It comes as no surprise then that there is an array of job opportunities, functions, and responsibilities in pre-clinical CROs. In this second part of a two-part series, we will look at some of those opportunities and examine job functions, requirements, and advancement prospects. The first article focused on more traditional job roles within CROs including technical positions (animal care technicians, research technicians, and veterinary technicians), study management (including study directors), veterinary positions and quality assurance opportunities.This article will focus on emerging trends, consulting positions, and other opportunities within CROs.

Animal Welfare
Promoting animal welfare in CRO operations is an importantmatter.As the field of toxicology changes to incorporate fewer animals, less painful/distressful procedures, and more alternative methods, it is incumbent upon CROs to ensure that animal welfare is a top priority at all times. Clients now include “animal welfare audits” as part of their prequalification and/or routine auditing processes to monitor animal welfare activities for outsourced studies.¹

Several animal welfare related positions exist at CROs across the globe. These positions include:

• Animal Welfare Leaders –Veterinarians or other well-qualified individuals serve as leaders within the CRO organization on topics related to animal welfare in biomedical research. Typical activities involve establishing local or global animal welfare policies, managing others involved with animal welfare, interacting with animal welfare associations as representatives of the CRO, creating and providing training to staff, and monitoring activities at critical vendors (e.g. laboratory animal vendors).
• Institutional Animal Care and Use (IACUC) Coordinators – Given the complexity and criticality of IACUC functions for a CRO, many are establishing full or part time coordinators. IACUC coordinators may or may not be within a larger animal welfare, regulatory affairs, and or/compliance group. Many coordinators will pursue the certification provided by Public Responsibility in Medicine and Research (PRIM&R) as a “Certified Professional IACUC Administrator.”
• Regulatory Affairs and/or Compliance Leaders – In the medical product development field, regulatory affairs refers to navigating through the FDA’s or another agency’s approval process. However, organizations in laboratory animal science, including CROs, are now adopting and using that term to refer to individuals who help an organization navigate through the myriad of animal welfare related regulations, agencies, and guidelines as well as manage the associated paperwork and communications. Alternatively, “compliance” or “regulatory compliance” positions might also be seen. For those involved in regulatory affairs and/or compliance, it is imperative that they establish mechanisms to keep on top of new and emerging regulations, guidelines, and industry standards.
• Enrichment and/or Behavior Technicians/Leaders – Programs for the psychological well-being of non-human primates used in research are required by the Animal Welfare Regulations.² An exercise program is required for canines used in research who meet certain criteria according to the same regulations. Beyond the regulations, many species do better with active enrichment, behavior modification, and other training programs meant to enhance animal well being. CROs have begun to create positions dedicated to these programs. Sometimes the work is combined with an employee’s normal work, such as an animal care technician who in addition to his/her own work supervises the environmental enrichment of some animals, or full time employees may be devoted to these efforts. Some CROs, especially those with multiple locations, may form enrichment committees or similar groups to help implement procedures or share practices across sites and facilities.