This two-part series will look at job functions, requirements, and advancement prospects in pre-clinical CROs.
Career opportunities are the next focus of our journey into the world of pre-clinical contract research organizations (CROs). As mentioned in previous articles about 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 a two-part article series,we will examine those opportunities and examine job functions, requirements, and advancement prospects. This article will focus on traditional job roles while the next will focus on emerging trends, consulting positions, and other opportunities within CROs.
Just like other laboratory animal facilities, the backbone of facility operations is the technician. Technicians can focus on performing technical/ research procedures or animal husbandry.1 For most CROs, although not all of them, there is a division of work between research and animal husbandry technicians. Schedules must be carefully coordinated to allow for both functions to occur given the often critical procedure time points involved in pre-clinical studies.
Research technicians focus on the procedures to be done in animals as part of the pre-clinical study.2 This can include blood or other fluid collection, administration of test compounds (also called test articles), recording data, observing animals, assisting veterinarians and study directors, and other tasks. Other technical opportunities include performing surgeries, performing necropsies, running lab work, preparing test articles for administration (often called “formulation”), scheduling studies, and preparing “data packages” which represent the study notebook and is where all data is collected and documented (sometimes this is computerized). Several CROs have specialized these roles to the point where they have technicians dedicated to just these responsibilities, e.g. necropsy technicians. Research technicians, in particular, may have substantial client contact while performing study tasks when clients are present. On the flip side, clients may come in to specifically train technicians in procedures. These activities represent great learning opportunities.
Animal husbandry technicians focus on maintaining the appropriate housing environment for the animals depending on which type of study they are on. They will provide feed, water, bedding, clean cages, environmental enrichment, and other items to animals while maintaining the overall cleanliness of the facility and its equipment. These personnel have a critical role in monitoring animals and the facility, and must alert others when problems are noted.
A veterinary technician job role may also exist at some CROs. As would be expected, they have a primary role of assisting the veterinarians with the veterinary care of the animals which can entail administering medications and performing procedures as prescribed by the veterinarians, assisting with diagnostic procedures such as fecal examinations and radiographs, assisting with surgeries, and monitoring the animals.1
Depending on the CRO and its capabilities, qualifications and experience requirements for technician positions can vary widely. However, it is important for the technicians to focus on gaining technician certification through the American Association for Laboratory Animal Science (AALAS) and other training to continue their career advancement. A college degree is many times required for non-animal husbandry positions and/or supervisory roles. With experience, training, AALAS certification, and education, it is hoped that technicians will progressively take on additional responsibilities and potentially move into management or other roles. AALAS also offers animal facility management certification through their Certified Manager of Animal Resources (CMAR) program (www.aalas.org).
For technicians with a focus on surgery, the Academy of Surgical Research (ASR),maintains a certification program for this field: Surgical Research Specialist (SRS), Surgical Research Anesthetist (SRA), and Surgical Research Technician (SRT) (www.surgicalresearch.org). A veterinary technology degree and/or license is usually required for veterinary technician positions but others may be moved into these roles with the appropriate experience and training.
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.
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.
Management positions for veterinarians can include facility operations (e.g. animal facility directors) or programmatic oversight of veterinary care (e.g. directors of laboratory animal/ veterinary medicine) or other undertakings such as managing a surgical unit. As more CROs establish global strategic plans, veterinarians in these management level roles may find themselves establishing global policies on veterinary care, animal welfare, animal procurement, and/or facility compliance.
As would be expected, a valid veterinary degree as defined in the Animal Welfare Act regulations is required to fulfill the role of the attending veterinarian for research facilities registered with the United States Department of Agriculture (USDA). Certification by the American College of Laboratory Animal Medicine (ACLAM) and/or an advanced scientific degree might also be required (www.aclam.org). Certification by the American College of Veterinary Pathologists (www.acvp.org) would be required for veterinary pathologists. Some CROs participate in laboratory animal medicine, veterinary pathology, ophthalmology, and other veterinary training programs. Trainees rotate through the CRO for set periods of time to gain invaluable experience on running and evaluating pre-clinical studies enabling medical product approval.
Advanced education in non-technical competencies such as finance, business acumen, and management as identified by leaders in the veterinary profession may facilitate a veterinarians’ advancement and opportunities at CROs given their business concentration. Pursuing a Master of Business Administration (MBA) or other similar degree would help with the development of non-technical competencies and could prove to be beneficial over a veterinarian’s career in CROs.
All GLP facilities must contain a quality assurance unit (QAU).This unit must be independent of the operational groups conducting the study and typically reports directly to the testing facility management. Individuals within QAUs monitor studies to assurance management that “the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with regulations” (FDA21CFR Part 58 –GLPs). They do this through maintaining a “master schedule” of all GLP studies being performed, maintaining copies of all protocols, inspecting the laboratories and facilities, submitting to management reports on studies, reviewing final study reports, and performing other assignments.Many QAUs play a role in organizing client audits of the CRO which includes follow up correspondence with the clients to correct any identified deficiencies from the audits. When a regulatory agency, such as the FDA, shows up for their unannounced visits, the QAU plays a major role in providing them the information they need and explaining operational processes.
CROs typically require a college degree in an applicable discipline for QAU jobs. GLP experience, sometimes obtained by working as a research technician or in another position, is highly sought after when hiring QAU staff. It is not uncommon to have experienced and qualified technicians (e.g. those with the highest levels of AALAS certification) move into QAU positions. Entry level QAU positions are usually called “associates” or something similar. There can be a career path to managing QAU's or staff within the units. The Society for Quality Assurance certifies individuals in quality assurance where one becomes certified as a “Registered Quality Assurance Professional” (RQAP) in the GLPs (www.sqa.org). This certification is highly valued in quality assurance circles.
- Pritt and Duffee, 2007 http://dels.nas.edu/ilar_n/ilarjournal/48_2/pdfs/v4802Pritt.pdf
- Conarello and Shepherd, 2007 http://dels.nas.edu/ilar_n/ilarjournal/48_2/pdfs/v4802Conarello.pdf
- Pritt, Samalonis, Bindley, and Schade, 2004 http://www.labanimal.com/laban/jobs/articles/33-4-38.pdf
Stacy Pritt, DVM, MS, MBA, CPIA is a Director with B. Braun Medical. She holds a MBA in Health Care Management, Masters of Science in Managerial Science, and a CPIA (Certified Professional IACUC Administrator) certification through PRIMR. She may be reached at email@example.com.