How are pre-medical students involved in clinical research?

[MagicSkittles]

For those involved in clinical research: How are pre-med students involved in clinical research? For example, how can pre-meds consent patients? I know that there are pre-meds who can be involved in consenting patients, but I'm not exactly sure how that works. What sort of skills would I learn as a pre-med involved in clinical research (as a Clinical Research Coordinator, Clinical Research Associate, Clinical Research Assistant, etc.)?

Thanks!

---

Members don't see this ad.

 

[MagicSkittles]

Can this thread be moved to the general forum? Didn't realize I was in school specific. Thanks

For those involved in clinical research: How are pre-med students involved in clinical research? For example, how can pre-meds consent patients? I know that there are pre-meds who can be involved in consenting patients, but I'm not exactly sure how that works. What sort of skills would I learn as a pre-med involved in clinical research (as a Clinical Research Coordinator, Clinical Research Associate, Clinical Research Assistant, etc.)?

Thanks!

 

[typhoonegator]

We use research coordinators to screen and enroll patients in observational clinical studies. All have to complete CITI training and certification and in some cases consenting individuals must be added to the IRB. For clinical research of a more interventional nature, such as trials of endovascular stroke therapy, for instance, the individual obtaining consent must be a physician licensed to practice in that hospital and on the IRB protocol. Research coordinators still participate in screening for these studies and are present for many of these consenting encounters and are typically better informed than the clinical fellow or attending obtaining the consent.

All our CRCs are post-undergrad people doing a couple years of research before going to med school or PhD school. They learn how to talk to patients, screen patients, draw blood (in some cases, not all), review medical histories, review charts, perform outcome scales and structured interviews, etc. The skills depend largely on the type of clinical research the CRC is going to be involved with. There are also "back of the house" coordinators that don't necessarily have patient contact, but process and store biospecimens, extract DNA, download and interpret imaging studies according to specific needs, etc. I try to get all my CRCs involved in primary research studies, manuscript and abstract writing as well, as a career building component of their work.

 

[TakemePRN]

I became involved after graduating and was lucky to get a job as a "Post-grad". It was a training position and exposed me to clinical research. And then through knowing people in the university I worked in, I became a research assistant and conduct clinical research now.

Most CRC positions will look for extensive research experience, patient exposure, and experience with different clinical databases or EMR. A lot of it can be taught. You have to have a bachelors degree though. I don't think you can do much if you're an undergrad or even get involved, especially if its a study investigating an upcoming drug or something.

I know three people in my undergrad who found their positions through connections. A professor at my school constantly looked for students he knew well that would want to work with his wife who was managing a clinical research position at a med school in another state so they moved after graduating and did clinical research for two years as part of their gap years.

Public health research in which you manage data are easier to acquire. I was involved in a summer research program and my public health research helped me to sell myself to clinical research positions. But I can tell you that getting a CRC position is not easy. You have to either know the right people or be VERY impressive on your CV or just get lucky with one. Awesome experience though and so much better than any other types of research.

 

[MagicSkittles]

We use research coordinators to screen and enroll patients in observational clinical studies. All have to complete CITI training and certification and in some cases consenting individuals must be added to the IRB.

How long does this training process take? I want to get involved, but most jobs seem to require at least a 1 year commitment, usually 2 year commitment.

Research coordinators still participate in screening for these studies and are present for many of these consenting encounters and are typically better informed than the clinical fellow or attending obtaining the consent.

How can research coordinators be more informed than attendings/fellows (i.e. what if a patient asks a follow-up question about a procedure that is about to be done, how would a premedical student who is a research coordinator)? When obtaining consent, is the research coordinator watching/observing the encounter or actively participating?

All our CRCs are post-undergrad people doing a couple years of research before going to med school or PhD school. They learn how to talk to patients, screen patients, draw blood (in some cases, not all), review medical histories, review charts, perform outcome scales and structured interviews, etc. The skills depend largely on the type of clinical research the CRC is going to be involved with. There are also "back of the house" coordinators that don't necessarily have patient contact, but process and store biospecimens, extract DNA, download and interpret imaging studies according to specific needs, etc. I try to get all my CRCs involved in primary research studies, manuscript and abstract writing as well, as a career building component of their work.

This is the part I'm really confused about, hoping to ask more questions about this. I've tried googling stuff like this to better understand what I would actually be doing on the job/what skills are needed or learned, but I don't really understand what I would be doing on the job.
What process are CRCs involved in when talking to patients?
What does screening and enrolling patients mean? Can you explain the nuts and bolts?
What does it mean to review medical histories, review charts, perform outcome scales and structures interviews? I've seen medical charts before and the language/ideas, and I don't understand how to interpret this without a medical background (medical school/training).
How can CRCs be involved in manuscript and abstract writing? How are post-undergrad individuals involved in manuscript and abstract writing without a background in medicine?

Thanks, I really appreciate your response. I've heard a lot of good things about CRC, but I don't understand what exactly I would be doing in the position or how I could contribute without a medical background.

 

[MagicSkittles]

I became involved after graduating and was lucky to get a job as a "Post-grad". It was a training position and exposed me to clinical research. And then through knowing people in the university I worked in, I became a research assistant and conduct clinical research now.

Most CRC positions will look for extensive research experience, patient exposure, and experience with different clinical databases or EMR. A lot of it can be taught. You have to have a bachelors degree though. I don't think you can do much if you're an undergrad or even get involved, especially if its a study investigating an upcoming drug or something.

I know three people in my undergrad who found their positions through connections. A professor at my school constantly looked for students he knew well that would want to work with his wife who was managing a clinical research position at a med school in another state so they moved after graduating and did clinical research for two years as part of their gap years.

Public health research in which you manage data are easier to acquire. I was involved in a summer research program and my public health research helped me to sell myself to clinical research positions. But I can tell you that getting a CRC position is not easy. You have to either know the right people or be VERY impressive on your CV or just get lucky with one. Awesome experience though and so much better than any other types of research.

Thanks for the reply. Can you explain what you do with clinical research? I've asked a lot of questions about CRC above. Was wondering if you had any input on your perspective for these questions?

Also, was wondering...what is your role in working with patients?

 

[typhoonegator]

CRCs know the protocols and the inclusion/exclusion criteria like the back of their hand, because it's essentially their only job. My ICU fellows could be enrolling for 12-15 studies overnight depending on the patient that shows up. They can't know everything.

Screening = finding out if patient is eligible, through chart review and talking to clinicians
Approach = talking to patient and family about research in general and a specific study they might be eligible for, finding out if they're interested
Consent = Reviewing the informed consent documents with the patient, answering their questions, and obtaining signed consent documents. I usually stand there while the CRC reviews everything with the patient and interject if there are any questions that I'm better able to field. Then I verify independently that they understand the risks and benefits and obtain consent.

Research coordinators aren't fully familiar with medicine, but they learn their segment of it by being immersed every day. If they like a specific question someone is working on, then they can get involved with the project, learn from the post-docs how to do the analysis, and then take a stab at writing it up. It takes a lot of guidance, but you see tons of post-CRC medical school applicants who have been on several papers.

 

[TakemePRN]

Sure. I can answer question by question...

Can you explain what you do with clinical research? --- I'm specifically on investigational drug studies that are assessing how some x drug interacts with patients that have x disease. I've been part of two departments so my first one was more directly working with the principal investigator of the study (PI) and he/she leads their clinical research team. These are MDs and ones who you go to for any patient related questions. This second department is the same thing but the PI is less involved. He just comes for physical exams and assesses any labs. I don't directly get to work with him though. And a lot of PIs work on sub-projects to get some papers published so yes, you can easily get published. I, unfortunately, didn't and wouldn't be bc I quit my first job due to problems with the team and this new job, although the PI works on papers on the side (I think?), I am less involved with him and work with a program manager who manages ongoing studies.

what is your role in working with patients? --- my role with patients is taking basic vital signs, asking them about any new complaints or any new medications, how they are tolerating the drug. It's direct patient interaction. MOST RAs and CRCs also draw blood but I haven't had a chance. I basically just ask the nurse or phlebotomist who's around bc I don't have training in that. I wish I did :/ ....oh and consenting patients to be part of the study and handling any issues that come about with them. Checking their labs and all

How long does this training process take? I want to get involved, but most jobs seem to require at least a 1 year commitment, usually 2 year commitment. - my case is a little different but yes typically a 2 year commitment because training is really extensive. It takes 6 months to actually adjust to it and there's a steep learning curve. 2 year commitment is best because you can then really understand everything that goes on and also develop a relationship with your patients.

How can research coordinators be more informed than attendings/fellows (i.e. what if a patient asks a follow-up question about a procedure that is about to be done, how would a premedical student who is a research coordinator)? When obtaining consent, is the research coordinator watching/observing the encounter or actively participating? -- they're not more informed than attendings/fellows. You handle conversations with the patients to the very basic level. Any medical related problems, concerns, or questions are handled directly with a doctor. You, as a RA, cannot give medical advice whatsoever, even if it's suggestions of supplements unless you've been there a while and know it's safe to do so but always just let the doctor handle that stuff. When obtaining consent, RA can either watch the PI or actively participate. It depends on the study and what their protocol is. RAs can consent alone but PI has to sign off on it -- and that's only if you can gain the PIs trust to handle such task. Messing up consents or not doing it appropriately is the most detrimental thing you can do in a study and cannot be messed with at all costs. It's sensitive material and if it's not done right then its bunch of ethic and HIPAA violations.

This is the part I'm really confused about, hoping to ask more questions about this. I've tried googling stuff like this to better understand what I would actually be doing on the job/what skills are needed or learned, but I don't really understand what I would be doing on the job. -- I explained most of it but you also have to process blood/urine samples and ship them appropriately. Watch out for their lab results and if anything needs to be reported to the PI. Fill out data in a clinical software and answer any queries. Review medications and complaints. Drug accountability; screen patients using EMR and watching out for serious events that need to a sponsor's attention.

What process are CRCs involved in when talking to patients? - Explained already

What does screening and enrolling patients mean? Can you explain the nuts and bolts? it means you look at who's eligible to participate in a study and enroll them into it. Usually it involves looking at patient's medical history and all.

What does it mean to review medical histories, review charts, perform outcome scales and structures interviews? I've seen medical charts before and the language/ideas, and I don't understand how to interpret this without a medical background (medical school/training). -- you learn basics and enough to get by. If you're searching for patients with diabetes 2 then you look at those patients but each study has its own inclusion/exclusion criteria and you have to fulfill all of them to enroll a patient into your study, like looking at their enzyme and blood values on EMR. You also look at their recent visits to the doctor and see what's going on with them etc.

How can CRCs be involved in manuscript and abstract writing? How are post-undergrad individuals involved in manuscript and abstract writing without a background in medicine? - you work with a PI and they can develop sub-projects with you and write. It can be an interesting case with a patient that's in your study or something. It could also be something PI is interested in that doesn't have to do with the study you're working on.


All in all -- best experience and most worthwhile. If you get this opportunity, don't hesitate. It's amazing and will teach you so much. Goodluck

 

[MagicSkittles]

what is your role in working with patients? --- my role with patients is taking basic vital signs, asking them about any new complaints or any new medications, how they are tolerating the drug. It's direct patient interaction. MOST RAs and CRCs also draw blood but I haven't had a chance. I basically just ask the nurse or phlebotomist who's around bc I don't have training in that. I wish I did :/ ....oh and consenting patients to be part of the study and handling any issues that come about with them. Checking their labs and all

Thanks for the post...very helpful! Was also wondering about what percentage of your time is spent working with patients directly (i.e. directly talking with patients)? Also, what percent of your time is spent with patients in some capacity (i.e. they're in the same room, whether you are observing or working directly)?

 

[TakemePRN]

Thanks for the post...very helpful! Was also wondering about what percentage of your time is spent working with patients directly (i.e. directly talking with patients)? Also, what percent of your time is spent with patients in some capacity (i.e. they're in the same room, whether you are observing or working directly)?

I would say 50/50 on directly working with patients and processing specimens, and 10% regulatory like inputting data, prepping for visits, coordinating study drug. The place I work is really busy bc we have big studies and small team and politics so I’m directly involved with patients. Whenever the physician has to do an examination, which is perdiocally, then I just stay and watch or do something else depending on the mood. And i can also go to lecture and grand rounds because I’m in an academic center but I don’t go lol.

I’m seeing patients basically everyday. At least 2 patients and maximum of 6 per day. Seems like it’s not a lot but it is. My other clinical research job was much slower so I was seeing 2-3 patients a week. The PI was more involved with us though so she had us work on papers, do preliminary research, attend grand rounds, lectures, talks, etc so it was more comprehensive. I personally hated that and LOVE my position right now. It’s hectic and tiring but patient interaction is strong

 

[MagicSkittles]

I would say 50/50 on directly working with patients and processing specimens, and 10% regulatory like inputting data, prepping for visits, coordinating study drug. The place I work is really busy bc we have big studies and small team and politics so I’m directly involved with patients. Whenever the physician has to do an examination, which is perdiocally, then I just stay and watch or do something else depending on the mood. And i can also go to lecture and grand rounds because I’m in an academic center but I don’t go lol.

Thanks!