Clinical Research Associate (CRA) – How to Become a Effective CRA

The Clinical Research Associate (CRA), also called the monitor, is the principal communication link between the sponsor and the investigator.

A CRA sets up, monitors and completes clinical trials. The CRA plays a pivotal role as he/she oversees the initiation, progress of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well being of human study subjects.

A CRA has an extensive set of roles and responsibilities in a clinical study include ensuring the well being and safety of the subjects, coordinating with the ethics committees, ensuring the authenticity of the data entered into the CRF, ensure GCP guidelines are followed, make sure the investigational drugs are accounted for, all the adverse events are reported and ensure that all regulatory documents are properly filled.

The ideal requirement for a clinical research associate is to possess an academic degree in life sciences along with a good knowledge of GCP, processes in drug development and local regulations. The CRAs are generally employed by pharmaceutical companies, contract research organizations, academic institutions, or site management organizations.

In the current industry settings, there exists a mismatch between the demand and supply of knowledgeable and trained CRAs.

Training:

Persons who aspire to be CRAs should take up CRA specific training in order to know the nitty gritties of the roles of a CRA in the clinical trial process. The candidates should make sure that they will learn practical, decision making and interpersonal skills in the process.

The training should ensure that you will have the knowledge of the following before you take up the responsibilities of a CRA:

o Good knowledge of the drug development process
o Knowledge of the GCP guidelines
o Ethical and regulatory guidelines of the country
o Good interpersonal skills
o Good communication skills

Clinical Research Associates – Career Insights for CRA Jobs

There’s a reason why Clinical Research Associate jobs are in such high demand. Working as a CRA offers good pay and a relatively high degree of personal autonomy, and much of the time, you can work from a home office. It’s a rewarding career that offers a good mix of solo time as well as working with others, and CRAs really feel like their work matters, because they contribute to the safe development of new drugs that can improve people’s lives.

In order to succeed in starting a career as a CRA, you’ll need to recognize that CRA employment has changed and is continuing to change as pharmaceutical companies adjust their business model to deal with changing economic conditions and business drivers. Four of the most common CRA employment arrangements are discussed below.

1. Direct employment by a pharmaceutical company.

If you are contemplating a career as a CRA, you’ve probably assumed you’d be working directly for a pharmaceutical or biotech company as a full-time, salaried employee. For many years, this was indeed the most common employment model. Companies that were developing a new drug would design their own clinical trials, and would send their own staff out into the field to develop new trial sites, manage patient recruitment and monitor trial activities. CRAs loved this, because working for a big company felt secure, and they often received generous salaries and benefits. On the downside, CRAs who worked directly for pharmaceutical companies often ended up with a very specialized focus in a single therapeutic area. They didn’t get exposure to other clinical protocols, and were sometimes required to travel over huge geographic regions. In recent years, many companies have decided to outsource their clinical operations to CROs, so while some CRAs still work directly for pharmaceutical firms, their numbers are dwindling.

2. Direct employment by a Contract Research Organization (CRO).

CROs started to become a major player in pharmaceutical development about ten years ago. During the early 2000’s, “Big Pharma” companies were under pressure from stockholders due to declining revenues, patent expirations and increased R&D costs. Management was encouraged to focus on core competencies (drug discovery and marketing), and outsource the rest wherever possible. At the same time, tremendous growth in the biotech industry was creating companies that didn’t have the internal resources to carry out trials on their own. Contract research organizations allowed both Big Pharma and biotech companies to effectively shift clinical operations out-of-house. The CRO industry grew rapidly and now brings in nearly $20 billion in revenue every year. The biggest CROs (such as Quintiles, Covance, and Icon) are multinational powerhouses with offices worldwide. These mega-CROs are fully capable of managing massive global clinical trials. However, small CROs have been successful too, offering specialized expertise, flexibility, personalized service and reduced overhead to maintain their niche in the clinical research ecosystem. Clinical research associates at CROs often appreciate the opportunity to work on a variety of trials in different therapeutic areas. which can be great way to remain flexible for future employment opportunities. On the other hand, CROs can be very demanding, and some CRAs find working with different trial protocols over a short period of time to be confusing and frustrating. Travel requirements are often quite reasonable, as many CROs deploy their workforces regionally. Salaries and benefits are usually not quite as good as working directly for a pharmaceutical company, but after a few years of experience, CRAs typically find it easy to find new employment opportunities if they aren’t satisfied. In the current economic environment, global CROs may offer more stability than smaller, more local organizations.

3. Self-employed, independent contracting.

For many CRAs, part of the allure of the job is the opportunity for self-employment. Experienced CRAs are in high demand, and those with proven skills and good references often “break free” to set up their own businesses, picking up contracts from pharma companies or CROs. As independent contractors, they can choose contracts that suit their lifestyle and travel preferences, and can charge premium rates for their services. A skilled CRA working for him- or herself can easily earn $100,000 or more each year. However, this lifestyle does have its drawbacks. Self-employed CRAs pay for their own benefits and vacation time, and need to “sell themselves” to market their services, which requires a different set of skills. Ineffective business development can lead to long periods of “down time” without pay between contracts. At the end of long days of work and travel, the trials of business ownership aren’t always worth the potential increase in income and freedom. Recently, some independents have been finding it harder to find opportunities on their own. As companies become more sophisticated in the way they manage outsourcing, they often find it more efficient to sign a single contract with an outsourcing agency or CRO rather than managing stacks of separate contracts with independent consultants.

4. Employment through an outsourcing agency.

The most recent development in outsourcing has been the growth of specialized clinical staffing agencies. These companies claim to offer the best of all possible solutions to both pharmaceutical sponsors and CRAs. Unlike a CRO, these agencies provide only human resources (often CRAs, but also trial assistants, coordinators, project managers and others) who can help a company carry out a clinical trial. Whereas CROs often provide broader consulting services, the agencies’ business model gives sponsors complete control over protocols and trial activities. The sponsor can flexibly adjust the size of the clinical force as required. From the CRA’s perspective, the agency can provide the flexibility of self-employment while taking over the challenge of finding new contracts. Agencies can usually pay CRAs more than they would make as a direct employee of a CRO or sponsor but not quite as much as they would make as a fully independent consultant.

So, what does all this mean for someone hoping to start a career in clinical research? The continuing ups and downs of the pharmaceutical sector make it difficult to say for sure. However, it’s clear that employment patterns in clinical development have undergone a number of major changes over the past decade. Anyone aiming for employment in this sector needs to keep their eyes open if they hope to chart a clear path for their career. My best guess for the next few years is that big CROs will be fighting with outsourcing agencies for dominance. but that CROs will continue to offer the best opportunities for entry-level career development.

All About Clinical Research Associate Career

Choosing a career is a tough decision for most people these days especially with lot of competition for jobs, it certainly is not easy and has been known to be complicated. Since most professions these days are relevant and interrelated with one another, a lot of careers have now come up in clinical industry. One widely accepted profession that people venture in nowadays is in a clinical research associate career.

Clinical research conveys the most up to date therapies and pharmaceuticals out of the laboratory area to the bedside of the concerned patients. In reality this discipline tries to combine two distinct horizons, that is the clinic and the laboratory, it also aims to translate fundamental discoveries into therapies that would alleviate human incurable diseases.

Basically, the task of a clinical research associate or the CRA is to prepare and set up the monitors and to complete the conducted clinical trials. Perhaps you are wondering what a clinical trial is? It is the scientific discipline which aims to understand the effects, threats, efficacy and the advantages that a certain medicinal product may provide its users. Since trials needed to be performed just before a specific product arrives at the hospitals or even at the shelves of any local pharmacy.

Typically, these trials are carried out at a range of phases or “stages” which are often comprised of trials with healthy humans, at one point there are trials with patients who are suffering from a disease. After those testing, studies were performed subsequent to the launch of a latest product in order to supervise the safety and probable side-effects of the product during an across the board utility. Most of the time, these clinical trials are performed by pharmaceutical firms or contractual research organizations or the CROs on their behalf.

Before you venture into something it is important that you familiarize yourself with the usual tasks of your profession. In becoming a clinical research associate you would have to learn a lot of things. Few of the duties include building up and recording the trial procedures which includes the outline of the objectives, and the methods that were performed in the trial, presentation of the trial procedure to a direction finding committee, creation of a design for the data collection outlines which is popularly known as the case record forms or the CRFs.

In addition, associate also coordinates with an ethics committee of the country of practice, they are the ones who guarantee every trial subjects that their health and safety weren’t placed at risk during the performance of the protocol. They are also the ones who manage some of the regulatory authority applications.

Other than that they are also the ones who locates and assesses the appropriateness of a study center, along with the briefing of the doctors and consultants who are to perform the trial. They are also responsible for the preparation of the study centers which consist of the setting up of the trial materials, the supervision of the trial all throughout the process and the verification of the data to the CRFs whether or not it is consistent with the presented clinical notes.

Clinical Research Associate (CRA) – A Growing Career Path in Biotechnology / Pharmaceutical Industry

A clinical research associate (CRA) is a professional who oversees all aspects of clinical trial conduct. They oversee clinical trials to test drugs/medical devices/biologics/or in vitro diagnostics for their effectiveness, risks and benefits to ensure they are safe to allow on to the market. CRAs are also known as clinical trial monitor or clinical monitor. A CRA may be involved in some or all stages of the clinical trial depending on the type of position and the employer a CRA work for.

Type of CRA

In-House CRAs

CRAs who work for a sponsor company are called in-house CRAs. An in-house CRA may be overseeing all aspect of clinical trial conduct, from planning to clinical study report (CSR) generation for submission to regulatory bodies. Below are some job functions of an in-house CRA.

· Designs study documents such as, study designs, synopsis, site specific protocols, informed consent forms, case report forms, site study procedure manuals and project tools, monitoring plans, and tracking tools, clinical study reports, budget and contract negotiation.

· Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.

· Maintain frequent contact with and work effectively with investigators and coordinators.

· Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

· Review and resolve discrepancies in clinical data with clinical sites or through a contract research organization (CRO).

· Low amount of travel may be required (e.g. up to 25-30%).

Regional CRAs / Home-Based CRAs

CRAs who work independently from home are called regional CRAs or home-based CRAs. Regional or home-based usually don’t handle planning and preparation of clinical trials. They generally handle the monitoring function and oversee trial conduct. Thus, they can work from home and they usually travel quite a bit more than their in-house CRA colleagues.

· Performs independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits.

· Maintain frequent contact with and work effectively with investigators and coordinators.

· Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

· Review and resolve discrepancies in clinical data with clinical sites.

· High amount of travel may be required (e.g. up to 75-80%).

CRAs Who Work For a CRO

CRAs who work for a contract research organization (CRO) can be either in-house CRA or monitoring CRA. They usually work out of a CRO’s office. As the goal of the CRO is to provide full range clinical trial services to sponsor companies, CRAs who work for a CRO may be called upon to perform in-house or monitoring functions depending on the project and client’s needs. One note to mention is that CRO is sensitive to the economic cycles. When the economy is good, CROs may hire a lot of CRAs to meet the higher numbers of clinical trial demands. When the economy is bad, CROs may turn around and lay off CRAs as work demand reduces. In addition, CRAs who work for a CRO are expected to work hard. They may be assigned to oversee multiple studies with high number of sites (>10 sites). That being said, a CRA position at a CRO is usually a good way for a new CRA to gain experience. Another benefit in working at a CRO is getting exposure to a variety of therapeutic areas that may enhance a CRA’s credential and career progression.

Education and Skills Needed

Education

Although there are no exact rules, general educational requirements for a CRA role is typically a bachelor of science (BS) or a bachelor of art (BA) degree in life sciences, medical sciences, or healthcare related field such as nursing. Advanced degree is not required, but can be helpful for career progression.

Skills

CRAs perform variety of functions relating to clinical trial. As different functions require different skill sets, below are some skills that can be helpful in a CRA’s job performance:

· Excellent communication skills (both written and oral). This is important as CRAs work with clinical trial sites (Principal Investigator and staff), regulatory review boards, key opinion leaders (KOLs), and colleagues.

· Ability to motivate and train others. This goes along with the communication skills. CRAs will need to train and monitor the progress of clinical trial conduct at different clinical sites.

· Attention to details. CRAs will need to be able to see mistakes and identify incorrect trial data / results. The work also involves documentation and recording of information. Detail oriented skills is critical to the monitoring work to ensure that clinical trial results are recorded appropriately and are accurate based on source data on medical records.

· Problem solving skills. Unexpected events and issues often will come up throughout different phases of clinical trial. CRAs are the main contact for all the issues that may come up. Thus, CRAs should maintain flexibility and positive approach toward unexpected issues.

· Multi-tasking, time management, and organizational skills. Multi-tasking skills are essential as CRAs are often handle different tasks at the same time. Time management skills are the key to effective work schedule arrangement in order to avoid overload. Organizational skills will help CRAs when working with stringent record keeping and regulatory requirements from regulatory bodies that regulate clinical trials.

· Ability to travel. Although travel can vary depending on the type of position, CRAs are expected to travel to clinical sites as needed. Ability to handle travel both domestically and internationally is one of the skills needed for CRAs.

· Knowledge of good clinical practice (GCP) and FDA Code of Federal Regulations (21 CFR 11, 50, 56, 312, 812, 45 CFR 46). These are some of the documents that govern clinical trial conduct. Familiarity with these documents is essential. If you are new to the industry, they can be learned.

How to Get Into a CRA Role

It’s not impossible to get into a CRA role straight out of college. Some sponsors and contract research organizations (CROs) may recruit recent graduates with the necessary traits and skills. However, most employers will require some relevant prior experience for a CRA role.

Experience

Similar to many other career fields, experience is the key to obtaining a CRA position. My own career path started with a bachelor of science in engineering. I worked in an academic research lab for 6 years after college before switching to a clinical research coordinator (CRC) role at a hospital for 3 years. From there, I transitioned into a clinical research associate (CRA) role at a sponsor company, an in vitro diagnostic device manufacturer, for 3.5 years. I then progressed into my current position overseeing clinical trial management at a non-profit drug company. Switching job had helped me gain experience and pushed me to develop new skills. In addition, every new position was an increase in responsibilities, job title, and compensation.

What if you don’t have prior experience?

This question came up when I switched my career path from working in an academic research lab to working in clinical research. It also came up again and again as I changed jobs into roles with greater responsibilities. The key to conquer new career path without prior experience are:

· Build on prior applicable skills and knowledge

· Willingness to work hard and start somewhere

These two factors were the reason that helped me transitioned into a clinical research coordinator (CRC) position in an emergency room setting at a hospital. I had applicable skills in science and research when I was in academic lab. The other factor was that I was willing to work at night and on the weekend. In addition, I had to push myself beyond my comfort zone. I was recruiting pediatric patients into clinical trials in emergency setting. Imagine yourself as a parent who brought a really sick child into an emergency room late at night, participating in clinical trial is probably not the first thing on your mind. This pushed me to work hard to succeed. I used the same approach to advance my career into a CRA role and into my current role as a manager.

Different pathways toward a CRA role

Similar to my career path, those without experience can get into clinical research at a lower level. These starting positions may be directly or indirectly applicable to clinical research industry. Once experience has been gained, a clinical research associate (CRA) position can be pursued using the applicable skills and knowledge acquired.

Directly applicable starting positions may include:

· Clinical research coordinator (CRC) role at a clinical site

· Clinical trials associate (CTA) role at a sponsor company

· Nursing role with patient care experience.

Indirectly applicable starting positions may include:

· Pharmacy or medical sales

· Clinical laboratory work

· Clinical data work

· Academic or pharmaceutical research

Clinical Research Training

Although experience is the key toward a CRA position, there are training programs that are offered through colleges and universities as well as online training courses that can help increase the chance for a candidate who looks to get into clinical research. These may include postgraduate degree and certificates in clinical research. The cost and time investment for these training programs should be considered carefully and compared to the pathways listed above for pros and cons. Training may also be done part-time while one work full time in one of the starting positions in clinical research. Specific curriculum will vary from institution to institution. Below are some general areas that a clinical research training program should cover:

· clinical research ethic

· clinical research practice

· clinical trial design

· clinical document writing (study design, protocol, informed consent, case report forms, etc.)

· clinical trial monitoring and management

· risk management

· regulatory requirements

Career Development

Career progression can be different depending on company and business environment. However, with motivation and previous experience showing success in clinical research, one should be able to progress either within the same company or at another company. Below are different levels of CRA title that we can use as a rough guide in gauging CRA career progression:

CRA Title

· CRA I – starting level with 1-2 years of experience. CRA I may be working on different parts of clinical trial, such as setting up trial master files, document preparation, and site correspondence. Some supervision from more senior CRA may be needed to help guide CRA I on different clinical trial related functions.

· CRA II – mid level with 3-5 years of experience. CRA II should be working on all stages of clinical trial. Job function can range from clinical trial design and planning, protocol and form generation, site selection, monitoring, to clinical report generation. CRA II should be working independently with little or some supervision from more senior CRA.

· CRA III / Senior CRA / Lead CRA – senior level with 5 or more years of experience. CRA III, Sr. CRA, or Lead CRA should be able to perform any of the clinical trial tasks proficiently. They are also expected to supervise, train, and mentor more junior CRA.

Beyond A CRA Role

Many CRAs may choose to remain in CRA role as a career. Some CRAs may become consultants after gaining years of experience. Beyond a CRA role, career progression may include management role such as:

· Clinical trial or clinical affairs manager

· Senior clinical trial or clinical affairs manager

· Associate director of clinical research

· Director / vice president of clinical research

The sky is the limit for opportunities and career progression beyond a CRA role. One note is that advance degree (M.D., Ph.D., MBA, etc.) may be advantage as one progress higher in clinical research career.

Clinical Research Associate Training – The Key to Becoming a Certified Professional

An ideal option for people who wish to build a solid career in the medical field, the clinical research associate profession brings many financial benefits and also a set of personal satisfactions, allowing practitioners to sustain their professional activity for the benefits of the community. Apart from the main function of monitoring clinical trials, the clinical research associate profession involves a wide variety of roles, such as verifying clinical site activities, making regular on site visits, reviewing and checking the accuracy of case report forms, as well as permanently interacting with clinical research investigators, all activities having to respect the imposed clinical protocols and good clinical practice guidelines.

It is important to note that the clinical research associate profession involves a lot of responsibility and dedication, rendering a long-term career in the branch quite demanding. However, clinical research associates have the opportunity to work in a clean and structured environment, to permanently interact with people and to ensure the protection of the rights, safety, health and well-being of human study subjects that participate in clinical trials.

The basic role of a clinical research associate, also referred to as a monitor, is to supervise the entire progress of clinical trials, initiated and conducted by physicians at hospitals, clinics, physician’s offices and other medical establishments. Apart from being responsible for the health and well-being of clinical study participants, clinical research associates have to ensure the accuracy, quality and integrity of the scientific data collected during trials. The extensive set of roles and duties characteristic to practicing clinical research associates include ensuring that the physicians respect good clinical practices and study protocols, checking the required documentation for each study participant, ensuring that all side-effects and adverse physical responses are appropriately reported and filed and ensuring the proper filing of various regulatory documents.

Clinical research associates are generally employed by pharmaceutical companies, medical research organizations and other institutions in the medical field. The profession involves a lot of field work, practitioners having to visit various sites and to maintain permanent connection with clinical study coordinators and investigators.

Persons who wish to follow the career of clinical research associate attend rigorous training programs to show good practical, decisional and communicational skills in the process. All persons who possess the skills and abilities required by the clinical research associate profession can easily obtain the proper training by attending clinical research associate training programs, regardless of their previous level of experience in the medical field.

Official clinical research training programs allow attending trainees to rapidly familiarize with the theoretical curriculum, and polish their practical skills and abilities required in their future profession. Instructor-led clinical research associate training programs are well-structured in a comprehensive manner, facilitating the process of learning and allowing graduates to leave with a complete baggage of knowledge and practical experience. A set of course examinations, self study and evaluations further prepare students for their final exams. The keys to becoming a well-trained, clinical research associate are attending to a proper clinical research training program and rigorously preparing for the final exams.