Transitioning into clinical research: the roles of the CTA and CRC

Today I’m going to write about two roles in clinical research that offer a good opportunity to transition into a pharmaceutical career. Clinical Trial Assistants (CTAs) and Clinical Research Coordinators (CRCs) both play important roles in the management of clinical trials. Both can be a good stepping stone for other, more coveted roles, such as clinical research associate or clinical project management jobs. However, they aren’t quite the same, and understanding the distinctions will help you to understand how one of these entry-level clinical research positions can fit into a long-term career in the pharmaceutical industry.

A clinical trial assistant (sometimes also referred to as clinical trials administrators or clinical research assistants) usually work for pharmaceutical companies (trial sponsors) or contract research organizations (CROs). Their role is primarily office-based, and their responsibilities involve providing support to other members of the clinical research team. They track and file documentation (such as trial protocols and case report forms), coordinate meetings and teleconferences, and help to manage timelines and budgets. As with anyone involved in clinical trials, it is essential to understand and follow ICH-GCP guidelines.

At myjobsearch.com, Charlotte Parker, a clinical trials administrator for a pharmaceutical company, describes her job:

I love my job; every day is different. I could be raising purchase orders, scanning documents into our electronic trial master file (electronic filing system for all clinical trial documents) or creating essential documents for the hospital staff working on the clinical trials.

I also regularly attend teleconferences and study-team meetings (I am now a well-practised minute-taker), co-ordinate ethics and research and development (R&D) submissions, and prepare for site initiation visits. This involves creating all the necessary site files and study specific materials. There are always things to be doing. (. . .)

I also work closely with hospitals. Each clinical trial protocol is carried out in a hospital (we call them sites or centres), and each site is managed by a clinical research site manager (CRSM). I currently work with around 15 different CRSMs. Some manage multiple sites over the different trials.

I also work with the co-ordinator of the clinical trial at each site to ensure that the correct essential documents are signed, completed and returned. Sometimes I have to communicate directly with the investigators (doctors), research nurses and pharmacists. I also work with 12 fellow CTAs. We support each other in our workloads and take on some tasks as a group.

In some ways, Clinical Research Coordinators represent the flip side of the CTA coin. Many of a CRC’s responsibilities are similar to those of a CTA, but whereas a CTA helps to manage the sponsor side of a clinical trial, a CRC’s role is to work closely with a principal investigator – a physician who is leading the conduct of a clinical trial at a research site (which may include independent medical practices or clinics as well as academic sites affiliated with a university hospital).

The CRC is usually employed directly by the PI, and is responsible for the coordination, management, and conduct of clinical research at the site. They may be involved with preparation of IRB submissions and informed consent documents, negotiating budgets and processes with the trial sponsor and institutional representatives (e.g. hospital administration), patient recruitment, adverse event reporting, preparing the case report form (CRF) and data management – again, all under strict ICH-GCP guidelines.

This recent article in the journal Nursing provides a good overview of the CRC role:

The CRC handles a diverse range of activities, including administrative, business, medical/nursing, and patient care duties. The CRC, like the clinical nurse, needs self-confidence, flexibility, and the ability to adapt to change. To comply with regulations and policies, the CRC must also pay close attention to details.

Fostering and maintaining good relationships will aid in recruitment and retention of study subjects (patients) and create an atmosphere of professionalism. A CRC also needs good people skills for dealing with representatives of sponsor companies, medical directors, administrators, and others involved in the study.

Eric Lee is a CRC who has an interesting blog about his career transition from academia to clinical research. He recently listed his responsibilities as a CRC at a university hospital:

- collaborating with Principal Investigators regarding new research proposals
- report preparation
- research accounts financial management
- assisting in the development and review of study protocols and preparing protocols for use
- preparing Research Ethics Board (REB) and grant submissions
- acting as a liaison between the REB and Principal Investigators
- developing and maintaining case report forms, data collection forms, questionnaires, parent information handouts, consent/ assent forms and all other research related documents
- performing data collection and entry
- chart requests from Health Records
- overseeing recruitment and patient contact
- monitoring and follow-up on serious adverse events and reporting to Principal Investigator and REB
- booking and coordinating research meetings with study collaborators from other
departments
- working with Biostatistician to develop randomization tables for randomized studies
- specimen shipping (certification for shipping dangerous goods required)

Other Responsibilities:
- designing/overseeing/managing the Medical Student IGT Summer Research Program
-collaborating with the Principal Investigator to apply for medical student funding
-acting as research supervisor for summer medical students and ensuring that students have a structured research experience with measurable learning objectives
-overseeing all REB applications for students and familiarizing students with REB procedures and documentation
-ensuring all students have required Research Ethics Board On-Line Training
-coordinating meetings between students and Principal Investigators
-providing access to data analysis programs or Biostatistician

While both CRC and CTA jobs provide excellent opportunities to transition into a clinical research career, there can still be challenges. CRCs in particular are often frustrated that their experience is often not valued more highly in the search for a clinical research associate job. As Eric notes on his blog,

A CRC helps the PI coordinate a study and protects the investigator’s responsibilities and the CRA monitors it.  At one point in time most CRAs began as a CRC! They gained some experience in monitoring some trials and ended up becoming full time CRAs. The process of becoming a CRA still eludes me! When I see entry level CRA jobs, it’s almost always required that the candidate have at least 1 to 3 years of monitoring experience. I think employers have to wake up and smell the roses. If it’s an entry level job, your target audience should be CRCs – ie. experience in coordinating clinical trials. The real difference as a CRA is this: you protect the sponsor with respect to conforming to international guidelines and regulations and as a CRC, you protect the investigators while conforming to the same guidelines. I think an experienced CRC knows what monitoring is all about after they’ve been monitored for all industry sponsored studies! I honestly have not seen any posts that hire entry CRAs without prior monitoring experience. Where the heck do you get the experience in the first place? Again, if you’re already a CRC or an assistant at a pharmaceutical company, you might have the opportunity to move internally into a CRA position. If you’re external, forget about it – to me, this frustrates me and is pretty stupid!

From my experience as a headhunter, I have some appreciation of the sponsor’s point of view. A CRC typically works closely with one, or possibly a few PIs, developing a strong working relationship and in some ways helping to defend or insulate the PI from sponsor demands. They will typically only handle a limited variet of trial protocols, usually within a single therapeutic area.

In contrast, CRAs work with many sites, and while it’s important for them to develop good relationships, sometimes they have to be the “bad guy” and take sites to task if they’re not measuring up. Add to this the fact that an academic or clinic environment is very different than the “real world” of industry: there are different stakeholders, different pressures, and an almost entirely different view of priorities and timelines.  While it is undeniable that CRCs have an excellent grasp of ICH-GCP and the trial process from the clinc perspective, they will need to prove that they also understand the ‘bigger picture’.

If you do land a job as a CRC, but hope to transition to a CRA role someday, the best way to manage these objections might be to avoid getting too comfortable. Don’t stay with a single PI or therapeutic area for too long — move around if you can, and try to develop a broad perspective. By showing that you can successfully work with a diverse collection of PIs, protocols and therapeutic areas, you’ll be able to build a strong case that you can succeed in a Clinical Research Associate job.

Good luck in your search!


Posted: August 11th, 2011 | Author: | Filed under: Clinical research, Clinical Research Associates, ICH-GCP | Tags: , , , , , | 3 Comments »

Transitioning from the lab to a Clinical Research Associate job

New Scientist recently published a career ‘case study‘, detailing how Linda Murray, a parasitologist and research assistant made the transition from the lab to a coveted job as a clinical research associate. After sending some resumes, she was lucky to land a role as a clinical trial associate with a CRO — an entry level step that gave her a good overview of the clinical research process.

Unfortunately, the article is not tremendously enlightening about what aspect of Linda’s approach led to her success. She had a friend who was already working as a CRA, which may have helped her to network and put her resume in front of the right people. Additionally, being able to ask someone who’s knowledgeable for insight into the industry can be a huge advantage — that’s basically what an informational interview is all about. Sometimes, luck plays a role as well — if a CRO has just landed a contract for a big new trial, they may need to quickly adjust their staff levels to manage the workload. You may be able to give yourself  an edge and increase your chances of being in the “right place at the right time” by reading trade magazines and industry newswatch websites to find out when trials are announced or contracts are awarded.

We’ve published a number of articles about the CRA career path that may help you find your own way to a career in clinical research.  Please check them out — and good luck in your search.

 


Posted: July 26th, 2011 | Author: | Filed under: Clinical Research Associates | Tags: , , , | No Comments »

Resources for your pharmaceutical job search

As you know, I am a huge believer that doing self-study and learning about the pharmaceutical industry job you hope to fill is an important step in preparing for a successful job search. These are just some quick links to books that might be helpful in finding a job in the pharmaceutical industry.

These books cover a wide range, from general pharmaceutical career advice, to detailed specifics about business development, pharmaceutical sales, medical science liaisons, clinical research, regulatory affairs and medical writing. I will follow up on each of these books in more detail in future posts.
Read the rest of this entry »


Posted: March 13th, 2011 | Author: | Filed under: Business Development, Clinical research, Clinical Research Associates, Medical Science Liaisons, Regulatory affairs, Resources, Sales | No Comments »

The future of CRA jobs

Clinical Research Associate jobs are in high demand. CRA jobs pay well, are often home-based, and offer a relatively high degree of personal autonomy. It’s a job that offers a good mix of solo time as well as working with others, and it’s a job where you can really feel like your work matters, because you’re contributing to the safe development of new drugs that can improve lives. The CRA role hasn’t changed a great deal over the years, with the exception of the increasing adoption of electronic methods for collecting case reports. But the nature of CRA employment has changed and is continuing to shift as companies change the way they do business. This article will discuss the four most common CRA employment arrangements and make some predictions for the future. Read the rest of this entry »


Posted: February 11th, 2009 | Author: | Filed under: Clinical research, Clinical Research Associates | Tags: , , , , , , , , | 8 Comments »

How to write a clinical research associate resume

This post will help you write a resume for clinical research jobs: entry-level clinical research associate jobs, clinical research coordinator jobs or clinical trial associate jobs would be good targets for this advice.

The hardest step to a successful career in clinical research is the first one. Getting your foot in the door takes patience, preparation, ingenuity and a toolkit of supporting materials and behaviors that will make you stand out above the competition.  A well-crafted resume can help you get your chance to shine as a clinical research associate, medical science liaison or other pharmaceutical professional.

There are a million guides out there that will give you good general advice on writing and formatting your resume, and (with one important exception) I’m not going to waste your time by duplicating that advice here. These tips are specific to the clinical research field. If you’re applying for entry-level clinical research associate jobs, the following suggestions may help your resume get noticed. Read the rest of this entry »


Posted: January 29th, 2009 | Author: | Filed under: Clinical research, Clinical Research Associates, ICH-GCP, Resumes & CVs | Tags: , , , , , | 13 Comments »

CRA training: How NOT to conduct a site visit

Here’s an amusing look at a day in the life of a CRA (Clinical Research Associate) on a site visit. This video is a parody, but it does give you a sense of what site visits are all about.

A CRA may spend 60-80% of their time on the road conducting these visits.  Their job is to monitor the conduct of clinical trials, ensuring that research sites are enrolling patients and carrying out the trial correctly, following both the trial protocol and ICH-GCP conduct guidelines. They review a lot of documentation, check site supplies and generally watch out for problems.

When there are problems, a CRA needs to help get the clinical site staff back on the right track, and so they need to have excellent communication and negotiation skills.  It can take a lot of diplomacy to get clinical investigators and their staff to change the way they do things in a busy clinic!

The sound in the embedded clip isn’t synchronized quite right.  You can see a higher-quality version at the ResearchPoint site.  They are the CRO (Contract Research Organization) that created the video.

You can read more about what a CRA job is all about in this earlier article.


Posted: January 27th, 2009 | Author: | Filed under: Clinical research, Clinical Research Associates, Fun | Tags: , , , , | No Comments »

How much does a clinical research associate earn?

How much does a CRA earn?

Clinical Research Associate jobs are in high demand, partly because many people think that becoming a CRA is a career pathway that will help them make money fast.

Are they right?

Applied Clinical Trials, a trade magazine for the clinical development sector, recently published its 2008 salary survey, which includes salary information for clinical research associates as well as other clinical careers.

According to the survey, independent CRAs earn more than anyone else in the industry — $115K on average — although it’s worth noting that as independents, they have to pay for their own benefits and the costs of marketing their services. Of course, there can be tax advantages to running your own business as well.

The mean salary for CRAs who weren’t self-employed was $76K.

You can read more about the survey at the Applied Clinical Trials website.


Posted: January 16th, 2009 | Author: | Filed under: Clinical Research Associates | Tags: , , | 1 Comment »

Watch out for scams in clinical research training programs

This is a subject that really makes me angry.  If you’re reading this site, it’s probably because you are anxious and hopeful, perhaps even desperate to find your first job in the pharmaceutical industry.  Unfortunately, there are a lot of people out there who are willing to prey on that desperation and take advantage of job-seekers.

A common way to do this is to offer ‘training programs’ of dubious value, usually offered online at a cost ranging from hundreds to thousands of dollars.  I’m aware of a number of these courses related to specifically clinical research and so-called ‘CRA training’. These courses will provide you with some information about ICH-GCP (which you could have found online for free), give you some online ‘exams’ (which you can often retake as often as you like) and in the end, give you a ‘certificate’ that you can print out and proudly reference in your resume.  What you don’t know is that industry recruiters are well aware of these scam companies, and the only thing that these certifications will indicate is that you were gullible enough to be taken in by a con artist — probably not the impression you wanted to make!

The most disgusting of these scam companies has created a whole empire of sham companies and organizations, building a web to lure you in.  They have a phony recruiting company, a phony industry association, and several phony ‘biotech companies’ and CROs.  These sham organizations will post fake job advertisements promising entry-level opportunities in clinical research.  When you apply, you’ll get an email telling you that sorry, you aren’t qualified, but you should consider taking a online training program, which they’ll happily refer you to.  If you’re ‘lucky’, you may even be told that you qualify for a special ‘scholarship’, offered by the phony industry association.

I don’t know why the guy behind this scam hasn’t been busted and hauled off to prison.  He’s probably scammed hundreds of thousands, if not millions of dollars out of desperate job seekers, many of them new immigrants, over the years.

Why aren’t more people aware of this scam?  Well, part of it is that the head of this operation seems to be litigious.  Many discussions about Clinical Research Training programs over at Indeed.com refer to the program, but critical comments are mysteriously removed after the ‘CEO’ of this company posts to ‘respond to his critics’.

If you read enough of these forums, you’ll find that a lot of people are taking these courses, and many of them will even recommend them.  Some of these sound like shills to me… if you’ve created a phony training program, creating phony supporters isn’t that much more difficult.  Others sound like genuine people who don’t want to admit that they’ve invested more than $1000 in a program that won’t help them get where they want to go.

I am not going to directly link to the fraudulent sites in this post because I can’t afford to be sued.  But I will link you to a forum where braver souls than I are discussing this scam.

So, if you are still set on getting some training to help you land that first pharma job, how can you stay safe and avoid getting scammed?

  1.  Avoid online courses if possible. If you must go this route, ensure that the course is offered by a legitimate organization, like an accredited university or a government agency. In-class training is almost always more valuable, especially if it includes a co-op or other hands-on element.
  2. Do your research! Use the power of the internet to search for discussions about the program you’re considering. Be extremely skeptical when reading positive reviews and pay close attention to any negative comments being made.
  3. Ask the experts. Try to speak to people who are actually working in the industry to find out what training programs they recommend. Check out the websites for professional association, and see which programs they recommend.  For clinical research, you should check out the Association for Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Of course, clinical research is not the only area where scam courses and certifications exist. I am also aware of some shady sites related to Medical Science Liaison training. Basically, any career path that is in high demand by job seekers provides an opportunity for con artists to take your hard-earned cash.  Be careful out there.


Posted: January 10th, 2009 | Author: | Filed under: Clinical research, Clinical Research Associates, Education, Medical Science Liaisons, Training | Tags: , , , , , , , , , , | 4 Comments »

What is a Clinical Research Associate (CRA) job all about?

Many people trying to obtain their first job in the pharmaceutical industry have a particular role in mind: the Clinical Research Associate, or CRA. These positions are seen as desirable because they typically offer relatively high salaries, a lot of independence, and are frequently home-based. In this post, I’m going to discuss the Clinical Research Associate’s role in detail: what do CRAs actually do? How does one obtain a CRA job? And what are the long-term career prospects for a new CRA?

As the name suggests, a Clinical Research Associates’s role in drug development begins at the clinical research stage, which is the point when human testing begins. CRAs may be involved with Phase I, II, III, or IV (post-marketing) clinical trials. A CRA’s main responsibility is to monitor clinical trials (and in fact some companies refer to CRAs as clinical research monitors). A CRA will travel to the clinical sites where trials are being conducted to ensure that all of the activity relating to the trial is in compliance with the protocol and ICH-GCP (Good Clinical Practice) guidelines. This may include reviewing the way patients are enrolled, to ensure that they meet the inclusion criteria; checking that clinical trial supplies are stored and dispensed appropriately; and reviewing Case Report Forms (CRFs) to ensure that they have been filled out correctly. In many ways, the CRA’s job is one of quality control, and many of the best CRAs pride themselves on having an extremely detail-oriented, “checklist mentality”. Of course, sometimes a site visit will reveal problems, and at that point the CRA must work with the staff on site to resolve outstanding issues. This can sometimes require a lot of charm and good negotiation skills!

Clinical Research Associates are frequently home-based, which is one reason that many people see this role as desirable, but this must be balanced against the fact that CRAs spend a great deal of time away from home. A CRA will typically be responsible for 5-10 different clinical sites, and will visit each one several to many times during a trial at a frequency determined by the protocol. This means that many CRAs are constantly on the road, and can expect to be away from home 60-80% of the time. Those working in urban centres may be able to drive to their sites, but regional CRAs must often fly to more distant locations. Many CRAs find the frequent travel exhausting after a few years of experience.

Historically, the major pharmaceutical companies that sponsor drug trials have been the largest employers of Clinical Research Associates, but this is beginning to change. Increasingly, these companies are outsourcing the operational aspects of the clinical trial process. Contract research organizations (CROs) such as Quintiles, Kendle, and ICON carry out trial activities on behalf of the sponsors. As a result, these days there are many more CRA jobs available with CROs than there are directly available with pharmaceutical companies. Many experienced CRAs choose to work independently, as self-employed contractors, working for a sponsor or CRO for the duration of a trial.

Working as a CRA for a Contract Research Organization can be different than working directly for a sponsor. In this position, CRAs often gain experience in many different therapeutic areas and work with many different protocols, which can be valuable for career development. However, they may also be required to monitor several different trials at the same time, which can be stressful. In contrast, CRAs working directly for sponsors sometimes complain because they are asked to monitor sites over much larger geographic areas, which can increase the amount of time they are away from their homes and families.

The Clinical Research Associate marketplace has been very competitive. Because CRAs are very much in demand, and their role is virtually identical in every company, it is easy for them to change jobs. CRAs are frequent targets of headhunters. As a result, companies have offered high salaries and excellent benefits in an attempt to buy employee loyalty. The pharmaceutical companies have typically offered higher salaries than CROs, but the shift in the marketplace towards outsourcing may be changing the dynamics of CRA compensation. Currently, a qualified CRA with less than 2 years of experience might reasonably expect to earn a base salary of about $60,000 and will see their salary potential grow quickly. It is not unusual to see CRAs with 3 years of experience earning in excess of $85,000. CRA compensation frequently also includes a company car and a competitive bonus structure. A CRA’s salary will normally max out at about $95,000. CRAs who go into business for themselves as self-employed contractors typically bill their services at $65-$100 per hour.

Many CRAs greatly enjoy their jobs and are happy to remain as clinical research monitors for their entire careers. Those who are looking for career development will typically move towards project management, becoming responsible for organizing a team of CRAs and managing operational aspects of trials. This in turn can lead towards senior roles in Clinical Operations.

To be hired as a Clinical Research Associate these days, an individual normally must have a degree in health sciences or life sciences. Many companies prefer to hire people with a Nursing background because of their familiarity with clinical settings. A very strong knowledge of ICH-GCP guidelines is essential. In terms of personality, a successful CRA must balance strong people skills with a very detail-oriented checklist mentality. It may be easier to get your foot in the door by starting as a clinical research assistant, or clinical trial associate instead. I’ll talk about this role in more detail in a future article.

Because CRA jobs are in demand, many courses and programs have appeared claiming to offer training that will help new job-seekers to obtain them. A number of colleges now offer post-graduate programs in clinical research that are respected by the industry; these frequently include co-op opportunities that give students real, on-the-job experience in clinical monitoring. In contrast, there are also many online courses and less reputable programs that will take students’ money, offer cursory training in ICH-GCP, and give graduates a certificate that is nearly worthless on the job market. One notorious company bills itself as a CRO, posts jobs online, and then steers applicants towards its expensive ‘training program’.  Unfortunately, having this company’s certificate listed on your resume is evidence of poor judgement, not good clinical training. Before spending any money on training programs, it’s important to do extensive research to ensure that you’re not getting ripped off.


Posted: October 28th, 2008 | Author: | Filed under: Clinical research, Clinical Research Associates, ICH-GCP | Tags: , , , , , , , , | 14 Comments »