Here's What You Need to Know to Get a Clinical Research Job

Here’s What You Need to Know to Get a Clinical Research Job May 25, 2017
By Mark Terry, BioSpace.com Breaking News Staff

A clinical research associate (CRA) is a health care or life sciences professional who oversees clinical trials on behalf of pharmaceutical companies, medical research institutes and government agencies. They are sometimes called clinical monitors or trial monitors. A key part of the job is to monitor Good Clinical Practice (GCP) guidelines such as the ones developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Salaries

CRAs tend to be classified by the Bureau of Labor Statistics (BLS) as clinical and medical informaticians. As such, starting salary range between $60,000 and $65,000, as of 2014. The Chron writes about CRAs: “The minimum educational requirement for this job is a bachelor’s degree in chemistry, biology or one of the life sciences. Some employers may prefer hiring entry-level clinical research associates who have one to three years of experience in clinical research but learn their job functions by training with experienced medical scientists. Other essential qualifications are observation, communication, critical-thinking, decision-making, data analysis and computer skills.” Payscale.com is pretty much in line with the BLS, citing a median salary of $61,984 with a low of around $42,000 and a high of around $91,000.

Payscale also notes, “For Clinical Research Associates, progressing to a Clinical Trial Manager role may result in a significant raise. On average, Clinical Trial Managers can earn $97,000 annually. Clinical Research Associates moving up in their careers tend to step into positions as Senior Clinical Research Associates or Clinical Project Managers. The median paychecks in those roles are $30,000 higher and $26,000 higher, respectively.”

Certification and Requirements

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified Clinical Research Associate (CCRA). It is not a requirement to be CCRA certified to work as a CRA, but it probably is an advantage. The ACRP notes CRA Certification eligibility includes documentation that you have worked independently of the investigative staff conducting research at a site or institution, which basically means you don’t report to the primary investigator or site manager and don’t have the ability to otherwise change or manipulate clinical trial data; that you do work on behalf of the sponsor, which is generally a pharmaceutical or device company, a granting organization, a physician or a university department.

It also compiles a lengthy list of duties that the applicant must have performed for a cumulative 3,000 to 6,000 hours. So clearly the CCRA is designed for people already working as CRAs. The educational requirements are a bachelor’s degree or higher and 3,000 hours performing essential duties, an LPN, LVN, RN or Associate’s Degree and a minimum of 4,500 hours performing essential duties, or a Medical Assistant, Lab Technician or High School Diploma and a minimum of 6,000 hours of performing essential duties.

Obviously, people with anywhere from 3,000 to 6,000 hours of experience must exist, so the question becomes, how does one get a CRA job? Are there shortcuts? Because the CCRA certification seems like a Catch-22—in order to be certified you need to already have the job, and to get the job, you need to be certified.

Education

Short of a rather circular line of thinking—get a job as a CRA to get experience as a CRA—there are educational courses. Numerous courses are online, but the CRA and other sources say to be careful—there are a lot of scams out there. In that respect, it would be a good idea before taking a course to make sure it is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Having a life science or medical degree is the strongest educational background needed. Keeping in mind that ICH-GCP is the heart of being a CRA, any and all coursework on Good Clinical Practice as outlined by the ICH is pretty much a requirement.

Shortcuts

It’s questionable if these are really shortcuts, or if shortcuts really exist, but here are a few ideas—or strategies—that might shorten the time to employment.

1. Prior experience.

Well, not really a shortcut at all. But there are Clinical Research Coordinator (CRC) and Clinical Trial Assistant (CTA) jobs. CRA Career & Jobs notes, “It may also be a good idea to volunteer for any duties related to clinical trials, but it’s far from enough.” Like all volunteering, make sure it’s valuable experience and that you aren’t being taken advantage of.

2. Consider the employers.

Very broadly speaking, CRAs work for pharmaceutical companies or contract research organizations (CROs). A CRO specifically handles a lot of the clinical trial work for biopharma companies, running the clinical trials and providing statistical analysis, resources, etc. CRA Career & Jobs notes that most people looking for CRA jobs hit the big companies first, ones like Johnson & Johnson , Pfizer or QuintilesIMS .

However, smaller biopharma companies, hospitals and even doctors’ offices may have a need for CRAs. In fact, CRA Career & Jobs states, “If you start searching online, you will eventually find many small to mid-sized CROs. Most people never apply for these companies, which is a shame, because it’s actually easier to get employed by these.”

3. Take relevant coursework.

Primarily in GCP. CRA Career & Jobs says, “If you don’t have any monitoring experience, you will increase your chances to get an entry-level CRA position if you take certain courses. If you have spent a couple of weeks, or preferably months, learning GCP you will meet the basic requirements to begin training as a CRA.”

4. Don’t only apply for advertised positions.

Admittedly, this seems counterintuitive. And by and large, big companies are going to post jobs and use recruiters. Smaller companies, though, may be more open to the “spontaneous” applications. To that extent, CRA Career & Jobs gives two pieces of advice: send your CV and cover letter to some companies that aren’t actively recruiting CRAs; and clearly state why you’re interested in the company “and you would be very happy if they contacted you should any open positions occur.”

Examples

1. Senior Clinical Research Associate for True North Therapeutics in South San Francisco, Calif.

Requiring a minimum of a bachelor’s degree, the company also wants seven to nine years progressively responsible experience as a CRA in the pharmaceutical industry. Responsibilities involve acting as the lead for management aspects of one or more clinical trials, including “management of day-to-day activities of vendor outsourced clinical site activities, including ensuring vendors meet related deliverables” and “ensuring development of site-level Study Documents (e.g. reference manuals, CRF Completion Guidelines, forms, etc.) and availability of site supplies within designated timelines.”

True North describes itself as a clinical stage biopharmaceutical company. Its lead product candidate is TNT009, which selectively inhibits a target in the classical complement pathway. It is being developed for treatment of various rare diseases mediated by the complement system in hematology, transplantation, and dermatology. The company is also developing next-generation anti-C1s antibodies for various rare diseases.

2. Clinical Research Associate – Acerta for AstraZeneca Pharmaceuticals in Redwood City, Calif

The position calls for a minimum of a bachelor’s of science degree and two or more years of relevant clinical experience at a CRO or pharmaceutical company. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma. This position would work with Acerta’s lead program for acalabrutinib, an investigational covalent Bruton tyrosine kinase (BTK) inhibitor being studied in several Phase III clinical trials. The clinical program, the ad states, “includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.”

The position handles day-to-day support to the Clinical Trial Manager for managing sites and vendors. “The Clinical Research Associate will be responsible for assisting with developing clinical study protocols, case report forms, informed consent forms and other study-related documents.”

It should be pointed out that, although this position is for Acerta, AstraZeneca, with headquarters in Cambridge, UK, employs over 50,000 people worldwide and brought in $23 billion in revenue in 2016. The company is involved in numerous clinical trials all the time in a broad range of areas.

What CROs Look For

Proclinical, a life sciences recruitment company wrote an articlean article in January on what CROs look for when hiring clinical research associates. They are:

1. Flexibility and willingness to travel.

Savlovschi-Wicks writes, “The most successful individuals won’t be in the clinical research industry for the money, but because they enjoy working towards making a change in people’s everyday lives and understand how their CRA job works within the bigger picture.” But the money isn’t too bad, either. It’s also worth noting that clinical trials are, pretty much by definition, cutting-edge life and medical science with big impacts, both in terms of what it does for people and economically for businesses.

2. True passion for clinical trials.

Savlovschi-Wicks writes, “The most successful individuals won’t be in the clinical research industry for the money, but because they enjoy working towards making a change in people’s everyday lives and understand how their CRA job works within the bigger picture.” But the money isn’t too bad, either. It’s also worth noting that clinical trials are, pretty much by definition, cutting-edge life and medical science with big impacts, both in terms of what it does for people and economically for businesses.

3. Realistic expectations.

Savlovschi-Wicks notes that CRAs sometimes run into problems when it comes to career progression. “While fast career progression may seem appealing, the reality is that you may be better off putting the brakes on and understanding what is realistically beneficial to your CRA career.”

4. Loyalty to your current CRO.

Apparently, it’s common for CRAs to take jobs with large, well-known CROs with global research, which provides them high-level training and development programs. They are then often headhunted by clinical research recruiters offering better pay. Savlovschi-Wicks feels this can cause problems later in your career if you’re viewed as a “permanent flight risk” because of job-hopping. To be fair, that’s hardly limited to CRAs. Her second point is that sticking with a CRO for a longer period provides you with higher quality experience. She notes, “One year’s experience in five separate CROs/pharma companies is not equal to five years’ solid experience at, for example, one of the top ten CROs.”

But all told, being a CRA can be a fascinating, well-paying job with numerous opportunities. Are you ready?

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