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: , , , , , | 4 Comments »

Book Bargain Alert: How to Break into the Pharmaceutical Industry

The Kindle edition of Daniel Danielian’s “A-Z: How to Break into the Pharmaceutical Industry” is currently available for just $2.99.  It’s a well-reviewed guide that provides advice for getting your start as a pharmaceutical sales representative.  It’s a quick read, and the formatting on Kindle is a little wonky (but not in a way that affects readability) but it gives a really good overview of what a medical sales job is all about and what’s required to be a success. On the other hand, it’s not the right book to turn to if you’re looking for resume advice, as it basically starts with the assumption that you’ve managed to get an interview — which for some people is the toughest part of “breaking in”.

On the whole, I would say that the price is right for this solid little introduction to a pharmaceutical sales career.

A to Z: How to Break into the Pharmaceutical Industry (Kindle Edition)


List Price: Price Not Listed
Kindle Edition: Check Amazon for Pricing Digital Only

 


Posted: August 10th, 2011 | Author: | Filed under: Sales | Tags: , , , | No Comments »

Effective cover letters for Medical Science Liaison jobs

I’ve been given permission to share another article from Dr. Samuel Dyer, the founder of the MSL World career site dedicated to the medical science liaison role. Here, he provides some advice about cover letters.  Dr. Dyer worked as an MSL manager for many years — it’s great to get the perspective of a hiring manager.

5 Strategies for Creating an Attention-Grabbing Medical Science Liaison Cover Letter

By Dr. Samuel Dyer

“Attached you will find my resume for the position of_______”. How many cover letters have you created and submitted that included such a standard opening? How many other candidates do you think have done the same? Put yourself in the recruiter’s or hiring manager’s position and imagine how tedious it must be to read submission after submission with these same or similar words.

Recruiters can easily receive 100’s of cover letters and resumes for each advertised MSL opening. As a result, your cover letter needs to grab the attention of the recruiter or hiring manager very quickly. Most employers will only spend a matter of seconds during an initial pre-screening or review of your cover letter. If it doesn’t grab their attention in some way, it will be discarded.

What strategy can you use to catch the attention of the recruiter or hiring manager? You need to use an attention-grabbing relevant opening while simultaneously remaining professional. In short, write something that will motivate the reader to learn more about you.

Here are five unconventional strategies to create an attention-grabbing opening:

1. Mention a previous discussion with the hiring manager

Obviously you can only pursue this tactic if you have spoken with this person. However, if you had shared such a conversation you have a distinct advantage. Start the letter by referring to this prior contact.

Example: “Thank you for taking the time to speak with me regarding the MSL role in the __________therapeutic area. This position is very interesting and seems to match well with my experiences and to what you and the company are looking for.”

2. Mention the name of the person who referred you

Recruiters and hiring managers are much more likely to remember a cover letter when it mentions a trusted colleague or friend.

Example: “Hello, my name is ______ and I received your name and contact details from John Smith. I am contacting you to learn more about the MSL role with _____ Pharmaceuticals that you are working on”.

3. Open the letter with a description of a major (and relevant) success

Concisely describe this major accomplishment and point out how you can achieve similar results for their company.

Example: “As a senior MSL with _______ Pharmaceuticals in CV, I was able to develop and manage significant KOL relationships which resulted in _____________. I would appreciate the opportunity to speak with you regarding the MSL role in (CV or specific drug) with ______ Pharmaceuticals.” (You need to match and relate your background, accomplishments, pre-existing KOL relationships within the same Therapeutic Area, or any other relevant experiences to the needs of the role and company you are applying to.)

4. Quote the hiring manager directly

If the hiring manager has been interviewed in the media or has posted a comment to a social media site or blog, quote the statement in your letter and highlight how your business practices and values are aligned.

Example: “In a recent interview you had with _________, you stated, “the MSL role continues to evolve as a greater number of KOLs increasingly recognize the important contribution that MSLs can make in the development of their research projects.” After reading this statement, I was confident that my relevant MSL experience of documented history of successfully working with KOLs on numerous research projects would be valued at __________ Pharmaceuticals.

5. Quote a recent industry article or statistic

Quoting an article or statistic relevant to the specific company or industry demonstrates your knowledge of industry trends, latest news, or recent developments.

Example: “The recent (for example-specific Medical Journal reference) article stated that ________ Pharmaceuticals CNS product (or drug) went into phase III trials for the treatment of severe pain. Having relevant experience of worked with two pain products in phase III trials while at _________ Pharmaceuticals, will enable me to play a critical role in assisting the company to be successful in this important step.”

The first paragraph should make it clear how your background and experiences fit well with the role and how you can add value to the team. If possible, try to make a connection with the company, the hiring manager, a mutual colleague, or some other relevance to your background to grab the attention of the reader.

Obviously, the most important factor that a hiring manager considers when screening applicants is that the candidate meets the minimum requirements for the role. However, when several candidates meet the initial criteria, one way to distinguish yourself is to write a unique cover letter to grab the attention of the reader to motivate them to arrange a telephone interview or screen.

If you’re not already working as a medical science liaison, you may be despairing that several of Dr. Dyer’s examples are written from the perspective of an experienced MSL.  It’s true that without direct experience, it will be that much harder to grab the attention of a hiring manager in your cover letter.  You’ll have to find other examples from your experience that illustrate the same objectives as the MSL role, such as your abilities to understand the clinical implications of new research, to build relationships, and to effectively communicate with scientific leaders.


Posted: August 9th, 2011 | Author: | Filed under: Medical Science Liaisons, Resumes & CVs | Tags: , , | 1 Comment »

Great advice for getting started as a medical writer

I’ve been meaning to post a link to “Chain the Wolf“, a great blog about Medical Writing, for a while now.  I’ve emailed back and forth with the author a few times over the past few years, and I was thrilled when she started putting some of her thoughts about her career path in medical writing and medical education to screen.

In her own words,

I’m currently a full-time freelance medical writer and consultant (2.5 years and counting). Most of my clients are medical communication companies and the projects are usually in the area of oncology, although I also dabble in neuroscience from time to time.

But how did I get here and why do I have this blog? I really struggled at a few points before getting to where I am now. (. . .)

I eventually thought about medical writing, so once again I had to seek out information. How does one get a job in that industry? Would it or would it not be a good career for me? I did everything from post angst filled questions on a forum board (Hi Ask Metafilter!), conducted many informational interviews, and after taking a few more steps, I was hired at a medical communication company.I still wasn’t quite happy as my real goal was to eventually become a freelance medical writer. For some reason, making the leap from fulltime employee at a company to an independent freelancer was difficult. Sometimes it was facing a fear. I also had to learn new skills and few people have training in how to run a business, even if it is simple. I was able to successfully make the jump but again, I do wish there had been useful resources for me. I still look for “how to run a business” type resources, and there isn’t really high quality information out there.

So I am creating this blog as a resource for people who like me, had questions; in a way, I am trying to pay it forward and put up this information for other people like the old me.

‘Chain the Wolf” (a phrase which refers to managing your fear) is fairly new, but has already featured many useful posts on getting started in medical communications, freelancing, and alternate career paths for PhDs.  It’s a great resource and I am very happy to recommend it.


Posted: August 7th, 2011 | Author: | Filed under: Uncategorized | Tags: , , , , , | No 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 »