Communication: The Key to Becoming An Exceptional Clinical Research Professional

Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs)are research professionals whose main responsibilities are to adhere to clinical trial protocol and assuring subject safety in clinical trials. One of the first things that CRA’s/CRC’s learn are fundamental industry standards, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Thanks to the guidance that these standards offer, CRA’s/CRC’s can effectively oversee and resolve many situations in translational research. However, CRA’s/CRC’s sometimes discount the fact that their training and understanding of ICH GCP is not enough. There are some things, however, that training does not teach. For example, Human Subject Protection training teaches clinical research professionals how to protect the subject from harm but does not teach them that bilateral communication is the first way to prevent the harm. In addition to familiarity with the clinical protocol, clinical research professionals must possess the ability to communicate articulately. Good communication is critical to productive work and error prevention in research.

Communication is not only used to exchange information but also to voice reservations and inquiries. In fact, most protocol deviations can be prevented when CRA’s/CRC’s express their concerns to others. But, some get so accustomed to following the standard operating procedures (SOPs) established by sponsors, guidelines created by institutional review boards (IRB) and regulatory agencies, that they hesitate to ask a question just because it seems unimportant or diverges from the sponsor’s, IRB’s, and regulatory agencies’ standards. Although CRA-CRC communication is pivotal in clinical research, they are not the only ones who share this responsibility. All parties involved in clinical research are responsible for communicating candidly.  Choose to be a part of a research team that doesn’t have any past regrets because its members carefully examine each material presented before them and openly communicate to one another.

It is then necessary to note two things. First, each Sponsor has its own SOP. SOPs differ from organization to organization, so, CRA’s /CRC’s should not make choices based on their previous learning experiences because what they learned may not apply to every situation or organization thereafter. Second, they may feel cautious seeking clarification because they may think that the inquiry is trivial but in truth, what may seem as a senseless question or concern may actually be very significant. For instance, a clinical research coordinator may read a certain page in a protocol and understand that the investigational product (IP) needs to be administered once daily after meals, but the principal investigator (PI) reads the same page and understands that the IP needs to be administered two times a day. Both the CRC and PI read the same page but understand two different things. If the coordinator follows the PI’s instructions of administering the dose two times a day and does not question the PI’s interpretation of the protocol, the situation can result in a major safety deviation. The CRC not only failed to fulfill his or her duties, but may have put the study or the research subject at risk. Bear in mind that humans both read and write the research protocol. Communication is vital in issuing protocol review and changes the way the clinical trial is performed. If the same question or concern is asked various times across multiple research sites, a protocol review will be initiated by the sponsor. Research staff, especially CRA’s/CRC’s whose main responsibilities are enforcing subject safety and maintaining quality research data must voice their concern. A concern that is not promptly externalized through communication can result in a major protocol violation, including adverse effects on subjects or lost clinical data. Unlike the CRC in the example, a CRC should not hesitate to voice his or her concerns before taking their next step. If he/she is unsure about a certain matter, it should be probed for more information, asking as many questions as needed, until a clear explanation is available. The choices clinical research professionals make can have irreversible consequences.

In conclusion, good communication is key to almost all aspects of research.It is a good idea for a CRA/CRC to be as explicit and elaborate as possible when asking questions and providing answers. This will assist him or her in understanding and communicating consistent and straightforward information. It falls upon CRA’s/CRC’s to act as the initial communicators and mediators between sponsors and study subjects. For example, research subjects would ideally follow all the instructions set by the clinical trial protocol but in reality, research subjects deal with real-life issues, such as unexpected situations and family concerns. Therefore, in a clinical trial, a research subject may end up taking the investigational product two times instead of three. When events like these take place, communication is imperative. Besides robust communication skills, it is crucial for CRAs/CRCs to uphold a strong communication channel between other members of the clinical trial protocol team  and collaborators. Indeed, the key to fruitful results in research is a strong, communicative bilateral relationship between CRA and CRC. Keeping the CRA-CRC communication channel continuously open will ensure team cooperation and support, especially regarding the safety of the research subject. Clinical research professionals should remember that they work with human lives and subject safety is always first priority.

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Clinical research

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is different from clinical practice. In clinical practice one uses established treatments, while in clinical research evidence is collected to establish a treatment.

The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.

In the United States, when a test article is unapproved or not yet cleared by the FDA, or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition clinical research may requireInstitutional Review Board (IRB) or Research Ethics Board (REB) and possibly Other institutional Committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which Federal regulations the research is subject to (e.g., [(Department of Health and Human Services (DHHS) if Federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.

Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants.

The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.

In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.

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Clinical research associate: Job description

A clinical research associate (CRA) runs clinical trials to test drugs for their effectiveness, risks and benefits to ensure they are safe to allow on to the market. They may work on new as well as existing drugs and are usually employed by either a pharmaceutical company or a contract research organisation (CRO) which works on behalf of pharmaceutical companies.

The CRA will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.

Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects.

Typical work activities

Tasks carried out by a CRA may vary depending on their employer but they will typically include:

• developing and writing trial protocols (outlining the purpose and methodology of a trial);
• presenting trial protocols to a steering committee;
• designing data collection forms, known as case report forms (CRFs);
• coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
• managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;
• identifying and assessing the suitability of facilities to be used as the clinical trial site;
• identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site;
• liaising with doctors/consultants or investigators on conducting the trial;
• setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards;
• monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis;
• verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
• collecting completed CRFs from hospitals and general practices;
• writing visit reports;
• filing and collating trial documentation and reports;
• ensuring all unused trial supplies are accounted for;
• closing down trial sites on completion of the trial;
• discussing results with a medical statistician, who usually writes technical trial reports;
• archiving study documentation and correspondence;
• preparing final reports and occasionally manuscripts for publication.

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The Journey of Clinical Trials

Without research, we wouldn’t be where we are today. Our profession truly makes a difference, and listening to some of the speakers continues to remind me why I love my job. The conference renews my spirit regarding the importance of my role as a CRA in ensuring patient safety and site/PI compliance.”Conference Attendee

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What Do You Find Most Exciting About Clinical Research?

By Stacey Carmody, CCRP

Someone recently posed the question: “What do you find most exciting about clinical research?” I find that it is hard to answer this is in just a few words. If I was to sum it up, I would say, “making a difference.” The role of clinical research is an awesome responsibility when you think about it. It determines which new drugs get approved that will enhance, or perhaps even save people’s lives. I find it exciting and humbling to be part of that. It is a great thrill to work with a drug that I later see gain FDA approval- to see it go from a number to a brand name. It’s kind of like knowing an unknown actor who finally becomes a star.

Another exciting aspect about clinical research is that it is never static. It always changes. There are always new treatments to study, and improvements to be made on the treatments we already have. Just when you think you have seen the best drug in its field, another one comes along that has promise to be better. Research never stops.

I also find it exciting when I have opportunities to connect with others who work in the profession. Logistically, research coordinators are often isolated in their private practices or hospital departments where there aren’t too many other coordinators around. Meetings and conferences have given opportunity for interaction, and the rise of social media have been especially beneficial.

I keep these thoughts in mind if I find myself aggravated- and anyone who works in this field can tell you that there will be times when you want to tear your hair out! In the worst times, you have to deal the demands of the study sponsors, the requests of the IRB, unpleasant monitor visits, noncompliant patients, stressed out Principal Investigators and so forth. There is also the strain of meeting enrollment demands, as in many cases, payment amounts to center depend on the amount of subjects enrolled in a clinical trial. Often, the existence of the research staff’s jobs depend on the amount of subjects enrolled. As unpleasant a thought that might be, it is a hard truth that clinical research is also a business and a competitive one at that, so there is a sense of urgency to enroll when you can. My former principal investigator was found of saying, “We’ve got to strike while the iron is hot!” The sponsor also has the pressure of deadlines to meet- which in turn is transferred to the participating center.

But all of this is quickly fades when I think about the main benefactors to research: the patients. Things happen when patients sign up for a clinical trial and come in for their visits. You get to know their personalities, their hopes, their fears. A relationship is formed. You find yourself rooting for them, hoping that the study drug will enhance their lives. Nothing gets more exciting than telling a study patient that the drug worked and that they are cured. To witness the looks of relief, the smiles, the tears of joy- is priceless. And it reminds me why I do what I do.

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Salary Negotiation – Do’s and Dont’s ?

During an interview or hiring process, it is common to discuss salary. This allows both parties to get a clear picture of what the compensation for the position will be. The salary for a clinical research associate can vary a lot depending on experience, personal skills and work duties. In some cases, parties may not see eye to eye and negotiations may be made. If this is done properly then it may mean getting the salary that you want. If not, it may mean getting less than you bargained for or worse, not getting the job at all.

• Do avoid discussing salary and such related matters early on. Some employers and companies may actually use this as a gauge in the early stages. Those who jump the gun may be cut off early into the process.
• Don’t be uninformed. Before you even set out to apply for a job make it a point to check the going rates for the position. This way you have a basis when you are asked about salary expectations. At the same time you can avoid making unreasonable compensation demands.
• Do know what the job is all about. Before you go about negotiating pay make sure that you know what the position entails. Consider the tasks you are expected to do as well and other areas of the job. If you skip this you may end up asking for higher pay that is not justifiable.
• Don’t feel compelled to accept the first offer. Many people often feel that they need to accept the first offer in fear of losing the potential job. Especially if you are applying for a CRA entry level position. If you feel that what is being offered is not sufficient, then go ahead and negotiate. Also, do not immediately accept the first offer if you have second thoughts about things.
• Do consider the benefits. Many of us tend to focus on the numbers during salary negotiation. Before you ask for more, consider the other things that you will be getting. Sometimes there may be some great benefits that make up for an offer.
• Don’t give false figures. When asked about your current salary, be honest. You do not need to give the exact figure, but give an estimate of what you make. Jacking up your current salary may backfire especially if your potential employer verifies it, making you dishonest.
• Do put your best foot forward. Sometimes it can be easier to negotiate when you know that you have an edge. Make a good impression during the interview and be sure to highlight your strong points and capabilities. Employers are willing to pay more for people who can make the company grow. This comes especially true for smaller CRO and pharma companies.
• Don’t forget to look in other areas. Sometimes companies or employers may not be very open to negotiating salary to the amount you want. If you can’t get the monetary value, try negotiating benefits and other perks such as longer vacations.
• Do seal the deal. Once you reach an agreement it will be best to get everything down in writing. This way you have solid proof of what was agreed upon.

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HOW TO BECOME A CRA: PART 1

“How do I become a CRA?”

This question is usually ended with “How do I get two years clinical experience when no one will hire me without experience?” or “I have a (fill in the blank) degree in Clinical Research and no one will hire me. What can I do?

As with anything in clinical research, the answer is HARDLY just one thing. Why does this drug cause a side-effect? Why does drug A work better than drug B? It’s hardly due to one singular component and the same thought can be applied to the path  to becoming a clinical research associate.

Before we start, let me tell you how I fell into the CRA role*.

I left college with a four-year degree in Cell and Molecular Biology, and a minor in psychology. When I graduated, my heart was set on being a genetic counselor and I said to myself:

“I will never work in a lab”.

My first job was as a bench biologist at one of the top three vaccine manufacturers in the industry. Sigh. So much for not wanting to work in a lab, right? I stayed at this company for about a year and half before I was contacted by a recruiter from a top CRO (contract research organization)(1) to apply for a scientist position. Long story short, I left the vaccine company for the CRO.

I always knew that I wanted to work with patients/people in general. Let’s face it, working in the lab is a lot like working by yourself. You’re not meeting with clients, doctors, patients, or really anyone beyond the lab walls. I knew that genetic counseling appealed to me, but I really like working with drugs and vaccines. One day, I was searching around the intranet of my company and I kept seeing “clinical operations” and “clinical management” and “clinical research associate”. I knew what a CRA was, but never really thought much into it. I saw that my company offered a CRA training program available to anyone who was….well, available to complete the two week training. My wonderful boss allowed me to complete the training, and that jumpstarted my career as a CRA. I was transitioned into a CRA role soon after completing the training and I couldn’t be happier.

My story is just one unique route of becoming a CRA. For example, I have a colleague that I’ve known since high school that graduated with a psychology degree and is now a clinical research coordinator at one of the top Ivy League colleges in the US (not quite a CRA, but he’s well on his way).

Here are some common steps and tips in becoming a CRA:

• Better Your Education
  • Most postings that you’ll find online for CRA positions require a four-year degree in Life Sciences. This can vary between biology, nursing, or any other degree that focuses on some science. If you don’t have this type of background, it might be beneficial to attend a university or college, even a community college, to begin your educational foundation. I would advise against looking for a certificate or Master’s degree in Clinical Research if you have zero clinical experience. Why? See the next bullet.
• Take a pay cut
  • This is the piece of advise that nobody wants to hear, but it’s probably one of the best options. Industry demands CRA’s have two years of experience before companies will even look at your application. How do you even get that experience? Many years ago, before HIPAA (Health Insurance Portability and Accountability Act in the US)(2), volunteering/shadowing was an easy way to gain experience. Nowadays, shadowing any clinical professional can be a breach of confidentiality and is becoming increasingly harder to find willing mentors. So what’s a job-seeker to do? Take a pay cut by getting a lower position in clinical research at a CRO or pharmaceutical company. Companies are willing to hire within, and if you think about it, it makes sense. They’re able to see your work ethic, performance, and they most likely trained you from the ground up. If you don’t have that “two-year experience”, instead of looking for CRA positions, look for Clinical Trial Assistant (CTA), Project Assistant (PA), Clinical Administration (CA), or Clinical Research Coordinator (CRC) positions. Whether site or sponsor based, these positions are the foundations of any good trial and assist the CRA in their day-to-day operations. These positions will train you the basics of clinical research.
  • Once you’re at a company that specializes in running clinical trials (such as a CRO or sponsor)(1), start looking for training programs that will continue your education in clinical research. Many companies have programs specifically for training new CRAs and these positions are internal ONLY – hence the importance of getting into a pharmaceutical company early into the process.
• Do Your Research
  • As much as you want to be a CRA, is the CRA role a good match for you? CRAs tend to travel around 60-80% of the time, though there is an increasing shift in in-house CRAs (I’ll go over this in another post). If you don’t have a vast clinical background, will you be willing to put in the extra work to brush up on clinical research? Go to your local library and pull books that will give you some insight onto the guidelines and regulations of clinical trials in your country. Subscribe to as many social media outlets that focusing in clinical research as you can – ACRP (Association of Clinical Research Professionals) and SoCRA (Society of Clinical Research Associates) are two organizations that have a large online presence with a lot of resources available (2).  LinkedIn is a great resource that can link recruiters with job-seekers very, very easily.
• Reach Out
  • I’ve met many a CRA that got their positions on simply on the basis of their passion and reluctance to give up. They were active in their job search and jumped at any and every opportunity to interview or ask more questions. Find a recruiter that will give you more information. If you’re not qualified for the position, ask what other opportunities might be available for you, or what skills you might need to brush up on. You need to prove to potential employers that you’re highly interested in becoming a CRA, and you have to take an active role in showing why.

• Capitalize On Your Skills
  • Pharmaceutical companies and CROs can specialize in a wide variety or narrow scope of “therapeutic experiences”. An example is that a large pharma company can specialize from oncology to infectious diseases and everything in between. If you have experience in a given specialty, make it known and keep continuing your knowledge in that area. Also, if you have experience in medical/scientific writing, pharmacovigilance, regulatory, computer programming, or data management, add it to your resumé and be sure to mention the clinical significance.

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source  CRA weekly blog

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HOW TO BECOME A CRA: PART 2

I’ve done everything you’ve said in your post. I have a four-year degree, some clinical experience, but I’m still not getting noticed. What do I do?”

This is tough, I’ll admit. You have the educational experience, the clinical expertise, and even a few ICH GCP and GLP courses under your belt. You’re either getting interviews, or you’re not. So let’s dig deeper.

You are landing interviews:

Aha! That’s half the battle. Landing interviews means (hopefully) that your resume/CV is relatively getting your career objectives across to recruiters. Let’s talk about the steps needed to have a successful interview and how to properly follow-up:

• Before
  • Research the company before you show up to the interview. Does their therapeutic experience match yours?
  • If you get list of people that are going to be interviewing you, Google them prior to meeting them. Why? For my first position as a Biologist right out of college, I found that one of my interviewers went to the same college and worked in the same research lab as I did. The interview was a breeze. He already knew my experience because I made it known that we worked with the same professor. Had I not searched for him on the internet I wouldn’t have be able to relate to my supervisor as well as I could have.
  • If a recruiter is involved in the process, discuss with him or her the company’s process for interviewing. Is it the STAR process?  How long will you be expected to be there and with how many people? Will you be engaging in a group interview? Any extra information you can gain will only benefit you
• During
  • Follow the essentials! Make eye contact, be professional, relate to the interviewers, and dress the part.
  • Always ask questions at the end of the interview. Remember, this is much as an interview for the company as it is for you. Some example questions can be:
    • “How do CRAs adjust to the amount of travel that’s required of them?”
    • “What resources does (Company Name) have for monitoring visits?”
    • “How long is the training program, if any?”
    • “How many studies will I be involved with?”
• After
  • Once you complete the interview, send the interviewers an email thanking them for their time. I always try to add in a personal note as well. For instance, if it was mentioned during the interview that your interviewer’s husband worked at the same company as you, I would mention that in the email. It shows that you were paying attention and taking note of personal/professional details.
  • Follow-up with the recruiter/HR at least once a week. Some people might think that one week is too often, however, keeping open communications with your recruiter is helpful. You want your recruiter to know your name. Let them know how the interview went and how you’re looking forward to the challenge of the new position.

You are not landing interviews:

So you have the experience, and you’re applying to jobs, but no interviews or even a phone call. What to do? Try the following:

• How’s your resume or CV?
  • What’s the difference? A resume, generally, is chronological, brief, and goes through the person’s employment as the focal point. CVs, or curriculum vitae, is a summary of your scientific background that includes any research experience, publications, presentations and awards. Personally, I find that a CV allows for a larger breadth of knowledge or content. Your CV should really discuss your clinical and therapeutic experiences. From my experience, recruiters and companies want action items of your accomplishments, not stock descriptions of your job. For example,
    • instead of saying, “Worked on several clinical projects within the hospital where duties included patient recruitment, performing study procedures, and maintaining case report forms”.
    • say something like, “Developed a Clinical Triage Process that reduced the workload for all clinical coordinators by 25%. This increased productivity by 62%”. This gives recruiters tangible items – you saved money by implementing a novel idea or process. Good deal!
  • Proofread, proofread, proofread. Many people that are reading your CV’s are extremely thorough and critical. In my past jobs, I’ve heard several stories of eligible candidates not being considered due to simple spelling mistakes. As ridiculous as this sounds, if you’re applying to be a CRA, one of your job functions is to catch the mistakes, large or small, an investigator makes in a clinical trials. Don’t ruin your chances because you spelled “clinical” incorrectly.
  • While writing my CV for the first time, I had the following thought in my mind. It was great motivation and I hope it finds you some inspiration:
    

    There are a ton of people in the world with the same skillsets as myself, applying to the same job. How can I make myself stand out in the crowd? What makes myself different?

    • For example, I’ve met a ton of CRAs with degrees in Cell and Molecular Biology (the same as mine :)). We all had basically the same educational background, but it was what we did with that degree that makes us different. I worked in a lab with vaccines (therapeutic experience) where others completed other projects. Only I know what skills my projects afforded to me and only I could describe that experience. As cliché as this sounds, only you truly know yourself. So write your CV with that in mind.
      • With the above in mind, be sure to capture what skills you have that can be applied to clinical research. These skills can be medical writing, SAS programming, Excel VBA macros, etc.
  • Once your document of choice is finalized, allow people to read it! Moms, Dads, trusted mentors in the field, anyone that has a set of eyes can critique. Ask them what areas you can improve on and hopefully they catch any spelling mistakes. If English isn’t your first language (which is the primary language of science), get a native English speaker to read the context of your CV and see if it makes sense.
• How is your online presence?
  • As I’ve mentioned before, reach out to recruiters. LinkedIn is a phenomenal networking and professional site. It puts your profile at the fingertips of thousands of recruiters looking to fill positions that you’re seeking. Find a recruiter that is posting a job (it happens all the time!) and contact that recruiter. Let them know that you’re interested and you wish to apply – be sure to note why you’re qualified and how you would be a good match for the company. A lot of times, job seekers describe how the job will benefit them – try to think from the other way around. You’re trying to get the company interested in you, and what can you bring to the table. Make that known at step one.
  • Social media is a wonderful tool. In addition to LinkedIn there are a variety of places where you can find professional support. Go to a conference specializing in clinical research. A simple Google search for “conferences and clinical trials” yields 13,700,000 results. That’s a lot of possibilities to get involved, join a professional organization, and learn more about your career field.

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source CRA weekly

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