Fundamentals of Working at a CRO
Contract research organizations (CROs) serve an important role in pharmaceutical and biotechnology research and development. Typically contracted by other companies to conduct studies, CROs are responsible for a variety of phases of research. They can handle anything from early-stage drug discovery to conducting clinical trials and managing clinical data.
Pharmaceutical and biotechnology companies contract with CROs because the companies may lack the right resources or desired specialization to conduct or manage these studies internally. Oftentimes, companies that use CROs are focused on developing a specific product or conducting a trial that could be out of scope for their regular activity. This is where CROs come in . They exist to complete a specific task cost-effectively and within the specified time frame. Although some companies utilize a CRO for one-off projects, others form partnerships with CROs for long-term benefits.
CROs are familiar with the applicable regulations and requirements, have experience managing similar studies, and know how to effectively collect the required data for the FDA, for example. When companies do not have the ability to conduct these studies in-house, it makes sense for them to rely on a CRO.
CROs are a vital part of drug development, helping convert an idea into a medication. They help bring cutting-edge medicines to market and are a necessary component of clinical research.
Popular Positions at CROs
Within the CRO sector, there are multiple potential career paths available. These include clinical research associate, project manager, data manager, biostatistician and regulatory affairs specialist to name a few.
The clinical research associate (CRA) will be the person who is the most visible to a life science client. They are responsible for the recruitment of sites, training the sites staff, monitoring the clinical trial and reporting back to the project manager. The CRA are responsible for ensuring Good Clinical Practice (GCP) and appropriate ICH guidelines are being adhered to, in addition to making sure that the trial sites are being supplied with the necessary information to successfully conduct a trial.
The client will normally report to the project manager. This is the individual who oversees all of the CRO’s activities to ensure that the project has been allocated the necessary resources and is running to schedule and to budget. Other responsibilities include the submission of documents to the regulatory authorities (e.g. the US FDA and EMA), preparing plans and reports as well as liaising with the client and ensuring a satisfactory audit trail.
The data manager is responsible for the collection and validation of all trial data and for collating a complete data set for analysis. Not all CROs will have this position so these activities may be carried out by another individual or even by the project manager themselves. If it is carried out by another individual, they may be referred to as a programmer or database manager. A biostatistician is responsible for the statistical aspects of the study which include the establishment of eligibility criteria, protocols and study reports as well as the design (which is very important to the whole study) and the analysis of the data. Some of their functions can overlap with those of the data manager. The biostatistician must have at least a Master’s degree level of training in statistics, or if they have only a Bachelor’s degree they should have completed a PhD in a biological or pharmaceutical subject and have taken some classes in statistics.
Regulatory affairs specialists are responsible for preparing the application for a clinical trial and eventually the drug registration application. They are also responsible for monitoring clinical research, as well as setting and monitoring regulations for the industry to ensure that the quality, safety and effectiveness of the product meet certain standards. This will involve meeting with regulatory agencies and health care providers. The regulatory affairs specialist coordinates the between the various departments involved in this process and is the company’s contact with the regulatory authorities.
Required Skills and Qualifications
Employers often look for candidates who have at least a bachelor’s degree in fields such as life sciences, biological sciences, statistics, or computer programming. A solid understanding of biology, chemistry, and mathematics also gives candidates an edge in the hiring process. Experience and familiarity with laboratory techniques and clinical trial processes is helpful. Employers prefer individuals with solid Microsoft Office proficiency, especially in Excel and Access.
Technical skills aside, employers also value several soft skills. They want individuals who possess excellent attention to detail, are focused and driven, and have strong communication skills. Those seeking to work as a project manager should have superb organization and multitasking skills. Additional desirable qualities include strong interpersonal skills, analytical problem-solving abilities, and a penchant for working with data.
Career Advancement Opportunities
Career growth and opportunities are often robust for those who work or wish to work for a contract research organization. Particularly in light of recent trends that have seen many CROs merging, there is a wider net of potential career advancement opportunities available to those already working for a CRO and those looking to join one. Many experienced professionals have successfully been able to cross-train at a CRO to broaden their job roles and learn new skills in order to continue to advance as they see fit . One of the central trends in the CRO job market lately is the fact that so many successful CROs have offices in separate countries. This creates many corporate-business travel opportunities, allowing members of a clinical research team to not only visit a foreign office, but even enjoy an extended stay as part of a project. These opportunities allow those looking to advance their careers in the CRO business to see interesting new parts of the world while also gaining invaluable professional experience in their field.
Pros and Challenges
The contract research organization (CRO) industry can be a highly rewarding career option, and in an increasingly globalized economy, more and more scientists, contract managers and corporate executives are specifically looking at CROs as potential employers. From the scientist’s perspective, being a key part of the drug development process is often a motivation. Still, working at a CRO is not without its stressful times. Short timelines and long hours are the standard, and deadlines can be tight. The work can be stressful as well, especially if you’re the team member responsible for submitting a drug application to the Food and Drug Administration (FDA) or another health authority. And because a CRA’s primary function is to ensure that clinical trials are performed according to the protocol, there is the constant challenge of monitoring standards at different geographic sites (if the trial is being conducted in multiple locations) and ensuring that close-out reports are compiled, reviewed and approved on time.
Similarly, someone with quality assurance (QA) responsibilities can face a great deal of pressure. Not only is the QA monitor responsible for assuring the quality of the trials, but their reports (which can also be a part of the official record) have the ability to either help or hurt a CRO’s credibility as it markets its services to other biotech and pharmaceutical companies.
Application Process for CRO Positions
Applying for positions within CROs is usually similar to applying for other jobs in health care. Company websites, medical journals, job fairs and word-of-mouth are all good sources for job leads. Typically you will apply online, via a computer system or e-mail. You will be asked to submit a cover letter, resume and references, and in some cases (such as designs or artwork) a portfolio. In addition, many CROs will not make offers until the applicant has completed a series of interviews, which may involve travel. Be prepared to be evaluated on several occasions over a period of weeks or months before an offer is made. Salary information is usually provided with any formal offer extended and is subject to negotiation.
The Association of Clinical Research Organizations , the trade group for the CRO industry, has a useful online Career Center that lists jobs. Industry journals Biocentury, Applied Clinical Trials and Contract Pharma also list jobs. If you have strong clinical or technical skills, adding some Inside knowledge of the workings of a CRO could make you highly marketable. Consider a position as a temporary, part-time or volunteer staff member to introduce yourself to the operations of an organization that you hope to work in. Often, these positions lead to offers for full-time employment.