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.
- 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
- working with Biostatistician to develop randomization tables for randomized studies
- specimen shipping (certification for shipping dangerous goods required)
- 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: Headhunter | Filed under: Clinical research, Clinical Research Associates, ICH-GCP | Tags: clinical research coordinator, clinical trial assistant, clinical trials associate, clinicalresearch, CRC, CTA | 2 Comments »