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Study Directors occupy a unique and mandated role within all pre-clinical CROs. These are the individuals who have the responsibility for the “overall conduct of a nonclinical [where nonclinical means pre-clinical] laboratory study” and “interpretation, analysis, documentation and reporting of results, and represents the single point of study control” (FDA21CFR Part 58 –GLPs). In other institutions, this position is usually referred to as the Principal Investigator or PI. Qualifications for being a study director can range from years of experience to a terminal college degree in a scientific discipline such as a Ph.D. or Doctor of Veterinary Medicine (DVM). In keeping with the good laboratory practices (GLPs) that provide the regulations for pre-clinical studies, “Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.” While this is important for all positions at a CRO, this is especially critical for study directors as management must determine that they are indeed qualified to perform the role. Documentation of training, experience, and education needs to be complete and thorough.3
Routine, acute, and small scale studies may have study directors with experience and/or an Associates or Bachelors degree at some CROs. Research technicians can, over time, potentially move into such a position. However, pivotal toxicology or surgical studies usually require a study director with an advanced degree. Opportunities exist for project managers, study coordinators, and other types of job functions that help manage and organize study conduct under the direction of study directors and facility management.
One exciting part of a study director’s job is interacting with clients. Clients (medical device, pharmaceutical, and biotechnology companies) often seek out expert advice from study directors with regards to choosing the appropriate animal model, study design, and testing procedures to enable acceptance of the study by the Food and Drug Administration(FDA).Study directors may build up a recognized expertise in a certain product area (e.g. medical devices, vaccines) and become even more sought after for their advice and study management/data interpretation skills.
Management responsibilities may or may not be a part of a study director’s overall job. Study directors may or may not choose to work into positions with increasing management tasks. Additional training in management (or non-technical) competencies may be advantageous if a person is seeking this type of career path. The management path may be appealing, but full-time management may require giving up the study director role.
Veterinarians
Core veterinary positions at CROs consist of the attending and clinical veterinarians. Sometimes these positions are called “staff veterinarians.” These veterinarians may have management responsibility for veterinary technicians or other facility staff. On rare occasions, staff veterinarians may also serve as study directors. While many consider this a conflict of interest, such combined expertise may help enable study conduct and animal welfare on certain types of studies.
Veterinary pathologists also carry out vital roles for CROs. A large data collection point for many pre-clinical studies is histopathology of organs and tissues. By careful examination of tissues underneath the microscope, highly trained veterinary pathologists can determine if test articles have adversely affected the animal. This information is highly valuable to the company making the test article and the FDA since the main goal of these studies is to determine if the test article is safe in animals.
Veterinarians have the primary role of providing veterinary medical care for the animals at the CRO. Maintaining regulatory compliance, supporting animal welfare, and performing study specific procedures upon request is also usually involved. Veterinarians are also called upon to be a part of initial conversations on study design and conduct. Working with study directors and clients, veterinarians can determine if the animal model is appropriate, what analgesics/ anesthetics/medications will be needed for procedure performance, and where additional veterinary support may be needed during study conduct. Training staff, from technicians to study directors, is also another important role of the CRO veterinarian.