A clinical research associate (CRA) is a professional who manages all aspects of clinical trial conduct. They oversee clinical trials to check drugs/medical devices/biologics/or in vitro diagnostics due to their effectiveness, risks and benefits to be sure they are safe to let to the market. CRAs are also known as clinical trial clinical or monitor track. A CRA may be involved in some or all phases of the clinical trial based on the type of position along with the employer a CRA function for.

Type of CRA

In-House CRAs

CRAs working for a sponsor company are known as in house CRAs. An in-house CRA could be overseeing all aspect of clinical trial conduct, from going to clinical study report (CSR) production for submission to regulatory bodies. Below are a few job functions of an in-house CRA.

· Designs research documents such as, study designs, synopsis, site certain protocols, informed consent forms, case report forms, site study procedure manuals and job tools, monitoring programs, and tracking tools, clinical study reports, funding and contract negotiation.

· Performs independent tracking of websites such as: Running website pre-qualification, initiation, monitoring visits, and close-out visits.

· Maintain regular contact with and work effectively with researchers and coordinators.

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

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

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

Regional CRAs / Home-Based CRAs

CRAs who work independently from home are known as regional CRAs or home CRAs. Regional or home-based typically do not handle preparation and planning of clinical trials. They generally handle the tracking function and oversee trial conduct. Thus, they can work at home and they usually travel quite a bit more than their in-house CRA coworkers.

· Performs independent monitoring of websites such as: Running website pre-qualification, initiation, monitoring visits, and close-out visits.

· Maintain regular contact with and work effectively with researchers and coordinators.

· Coordinate with the ethics committee, which protects the rights, security and health 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 working for a contract research organization (CRO) can be either in-house CRA or tracking CRA. They usually work from a CRO's office. As the goal of the CRO is to supply whole range clinical trial services to sponsor companies, CRAs who work for a CRO might be called on to perform in-house or tracking functions depending upon the job and client's requirements. One note to mention is that CRO is sensitive to the financial cycles. When the market is good, CROs may hire a great deal of CRAs to meet the high numbers of clinical trial demands. When the economy is poor, CROs can turn around and put off CRAs as work demand reduces. Additionally, CRAs working for a CRO are expected to work hard. They may be assigned to manage many studies with higher number of websites (>10 websites ). That being said, a CRA standing at a CRO is generally a great way to get a new CRA to acquire expertise. Another advantage in working at a CRO is getting exposure to a variety of therapeutic areas that may boost a CRA's credential and career progression.

Education and Skills Needed

Instruction

Even though there are no exact rules, general educational requirements for a CRA role is generally 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 level is not required, but may be helpful for career progression.

Skills

CRAs perform variety of purposes concerning clinical trial. As distinct functions require different skill sets, below are some skills which can be helpful at a CRA's project performance:

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

· Ability to motivate and train others. This goes together with the communication abilities. CRAs need to train and track the progress of clinical trial conduct at different clinical sites.

· Attention to details. CRAs will need to have the ability to see errors and identify erroneous trial information / results. The job also involves documentation and recording of information. Detail oriented skills is essential to the monitoring work to ensure that clinical trial results are listed appropriately and are accurate based on source information on medical documents.

· Problem solving abilities. Unusual events and issues frequently will come up throughout different phases of clinical trial. CRAs are the principal contact for all of the problems that may come up. Thus, CRAs should maintain flexibility and positive approach toward unexpected troubles.

· Multi-tasking, time management, and organizational skills. Multi-tasking skills are essential as CRAs are usually handle unique tasks at the exact same time. Time management skills are the key to successful work schedule arrangement in order to prevent overload. Organizational skills will help CRAs when working with strict record keeping and regulatory demands from regulatory bodies which regulate clinical trials.

· Ability to travel. Although travel can vary depending on the kind of position, CRAs are expected to travel to clinical sites as required. Ability to handle traveling both domestically and globally is one of those 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 a few of the files that govern clinical trial conduct. Familiarity with these documents is vital. If you're a newcomer to the industry, they can be learned.

How to Get Into a CRA Role

It's not impossible to get into a CRA function straight out of school. Some sponsors and contract research organizations (CROs) may sponsor recent graduates with the essential traits and skills. But most employers will require some pertinent prior experience for a CRA role.

Expertise

Very similar to several other career areas, experience is the key to getting a CRA position. My career path began with a bachelor of science in engineering. I worked at an academic research lab for 6 years following college before switching to a clinical research coordinator (CRC) role at a hospital for 3 decades. From that point, I transitioned to a clinical research associate (CRA) function at a sponsor company, an in vitro diagnostic device maker, for 3.5 decades. I then progressed into my present position overseeing clinical trial direction at a non-profit medication business. Shifting job had helped me gain expertise and pushed me to create new abilities. Additionally, every new position has been an increase in responsibilities, job name, and compensation.

Imagine if you do not have previous experience?

The question came up when I changed my career route from functioning in an academic research lab to working in clinical research. In addition, it came up again and again as I changed jobs into roles with greater responsibilities. The key to overcome new career path without previous experience are:

· Build on prior applicable skills and comprehension

· Willingness to work hard and start somewhere

These two variables were the reason that assisted me transitioned into a clinical research coordinator (CRC) position in an emergency room setting in a hospital. I had applicable skills in mathematics and study when I was in academic laboratory. Another factor was that I was willing to work through the night and on the weekend. Additionally, I had to push myself beyond my comfort zone. I had been recruiting pediatric patients into clinical trials in emergency setting. Imagine yourself as a parent that brought a very sick child into a emergency room late at night, engaging in clinical trial is probably not the first thing on your mind. This pushed me to work hard to succeed. I used the exact same strategy to advance my career into a CRA role and into my current role for a manager.

Different pathways toward a CRA function

Similar to my career path, those without expertise can enter clinical study in a lower degree. These starting places might be indirectly or directly related to clinical research market. After experience has been obtained, a clinical research associate (CRA) place can be pursued with all the pertinent skills and knowledge acquired.

Directly applicable starting places may include:

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

· Clinical trials associate (CTA) function in a host company

· Nursing role with patient care experience.

Indirectly applicable starting places may include:

· Pharmacy or medical sales

· Clinical lab work

· Clinical data operate

· Academic or pharmaceutical research

Clinical Research Training

Although experience is the key toward a CRA position, you will find training programs which are offered through colleges and universities in addition to online training classes which can help increase the opportunity for a candidate who looks to get into clinical research. These may include postgraduate level and certificates in clinical study. The cost and time investment for these training plans should be considered carefully and when compared with the pathways listed above for pros and cons. Coaching may also be done part-time while you work full time in one of the beginning 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 study clinic

· clinical trial layout

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

· clinical trial monitoring and direction

· hazard management

· regulatory demands

Career Development

Career progression can be different based on business and company atmosphere. However, with motivation and past experience showing success in clinical research, an individual should be able to advance either within precisely the same company or in another business. Below are various levels of CRA name that we can use as a rough guide in gauging CRA career development:

CRA Title

· CRA I - beginning level with 1-2 years of experience. CRA I may be working on various parts of clinical trial, such as establishing trial master files, document preparation, and site correspondence. Some oversight from more senior CRA may be required to help direct CRA I on various clinical trial related functions.

· CRA II - mid level with 3-5 decades of experience. CRA II ought to be working on all stages of clinical trial. Job function can vary from clinical trial design and preparation, protocol and form creation, site selection, observation, to clinical report generation. CRA II should be functioning independently with little or some oversight from more senior CRA.

· CRA III / Senior CRA / Lead CRA - senior level with 5 or more years of expertise. CRA III, Sr.. CRA, or Lead CRA should be able to perform any of their clinical trial tasks proficiently. They're also expected to oversee, train, and mentor more junior CRA.

Past A CRA Role

Many CRAs might decide to remain in CRA role for a livelihood. Some CRAs may become consultants after obtaining years of expertise. Past a CRA role, career development may include management function for example:

· Clinical trial or clinical affairs manager

· Senior clinical trial or clinical affairs director

· Associate director of clinical research

· Director / vice president of clinical research

The sky is your limit for opportunities and career development past a CRA role. One note is that progress degree (M.D., Ph.D., MBA, etc.) can be advantage as one progress greater in clinical research career.