How to choose a clinical research training program

It’s getting to the point where you can’t open a newspaper or current affairs magazine without reading an article about how difficult it is to get a decent job these days. See, for example, “The Youth Unemployment Bomb” in Business Week or “The Outsiders” in the Economist. Many new graduates leave college deep in debt, and find that their degree is not quite the ticket to ride they had thought it would be. As a result, many are deciding to head back to school to pursue career-focused postgraduate education.

Career colleges and ‘practical’ masters degree programs are a very visible example of supply and demand. If a particular job category is seen as ‘hot’, you can bet you’ll be able to find a college ready to sell you a postgraduate program promising to prepare you for the field. Some require a year or more of classwork, whereas others offer results from a short online program. Many promise internships, co-op placements and opportunities to network with industry professionals. This is definitely true of the pharmaceutical sector: there are almost too many programs to count offering classes, certificates and degrees in clinical research, regulatory affairs, pharmaceutical quality control, and just about any other role in the sector.

Personally, I think this is a pretty disgusting development. It used to be that new graduates would be given a chance at an entry-level role, and trained on the job. Their college diploma or graduate degree was sufficient evidence to show that they were smart enough and determined enough to be given a chance to perform. Many of the current leaders in the pharmaceutical industry got where they are after being hired right out of school with little or no ‘real-world’ experience. Nowadays, students pay through the nose for their undergraduate education, only to find that they are expected to pay even more when they finish. They attend career colleges in order to gain access to internships, paying tuition instead of receiving a paycheque as they get that vitally-important entry level experience. It seems like an incredibly exploitative system.

Clearly, this can be a treacherous – and expensive – path for someone who’s simply trying to get their foot in the door to begin their working life. If you are trying to fulfill your career goals of becoming a clinical research associate, for example, how do you navigate this maze of choices, avoid ripoffs and scams, and find a program that’s right for you?

If you have decided that some additional training is the right next step for you, here are some things to look for when researching and choosing which institution will receive your hard-earned dollars:

(1) Bricks and mortar. One of the greatest advantages that a career training program can offer is the opportunity to build your network with people who are, or soon will be working in the pharmaceutical industry. Online programs simply can’t offer the same chance to get to know your classmates and teachers.

(2) Professional faculty: Your program should be taught by people with current, real-world experience in the industry. The program website should offer detailed bios on all lecturers and guest speakers. Google their names, and make sure that their pharmaceutical industry experience is relevant, significant, and recent. Clinical research, regulatory affairs and other pharmaceutical careers are very dynamic. You want to be sure you’re learning from someone who has experience with the most current facets of the industry.

(3) Pedigree/Reputation. In order for the program to add cachet to your resume, people will have to have heard of it. For this reason, a program that’s affiliated with a well-known institution may be better than a small standalone career college. If you’re not sure about the program’s reputation, do some investigating! Post a question to a relevant linkedin group, or ask for recommendations during your informational interviews. You can also check with professional organizations (like ACRP or SoCRA for clinical research) to see what programs they suggest.


Posted: August 25th, 2011 | Author: | Filed under: Clinical research, Education, Resources, Training | 2 Comments »

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: , , , , , | 5 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 »

What’s it like to work for a CRO?

Over at ask.metafilter, someone has posed the question “what’s it like to work for a CRO?”

The person asking the question is a university research assistant with a background in cognitive neuroscience and an interest in statistics and applied math.

So far, one excellent answer has been posted. Read the rest of this entry »


Posted: June 12th, 2011 | Author: | Filed under: Clinical research, Preclinical R&D | Tags: , , , , | No Comments »

Free ICH-GCP Good Clinical Practice training course back online!

Great news! I have been able to find a mirror of the free online ICH-CGP Good Clinical Practice training course developed by MIT. Please see the original post for the updated link.


Posted: March 13th, 2011 | Author: | Filed under: Education, ICH-GCP, Training | 2 Comments »