Research Coordinator (Physician Services, System Research Suburban Plaza II)
- Originally an RN at Audubon in their Transitional Care Unit
- When Neuro ICU opened, Debbie assisted in the development of this unit
- Developed a love of making a difference for the patient, providing emotional support and nursing care for patients with neurological problems (CVA, tumor, trama)
- “Nursing Made a difference”
- While working in a physician practice, a pharmacology company helped train her to monitor a drug study overseen by this practice. She was excited to see patients progress.
- Went from being disabled to having a much higher quality of life because of the new pharmacologic therapies available to them
- Procedures: blood collection, run labs, complete patient assessments
- Point of Contact for research: pharma companies contact her if they have a drug to test
- She gathers the data from the company and reviews study for merit and value to the patient
- Communicates this to the physicians and works to determine if study is worth undertaking
- Work is gratifying because it provides patients access to new treatments and therapies they would not have otherwise had access to (esp multiple sclerosis drugs); watching safe, quality drugs go to market
- It also provides the experience/knowledge necessary to manage patients on medications which is shared with physicians and can be used by prescribing physicians for improved patient quality and safety
- Now works at Infusion center at Subrban (along with pt education, case managers and social workers. Would love to have physical and occupational rehab collocated there as well – “On our wish list”
- Really enjoys writing publications for research journals. “It gives me goose bumps to see the work we’ve done in print.” A pinnacle of her career was developing an academic poster highlighting a successful study and presenting that at a professional meeting.
During the study
- #1 job: patient advocate. Making sure patient is safe and has improved quality of life, that things are better for them, that the appropriate drug is prescribed for the appropriate patient, and that patient is followed appropriately.
- Monitors patient for safety and for effectiveness of medication (improved quality for patient – symptoms managed better, etc.)
- Analyze test results to ensure that the pharmacologic therapy is working as it should be as advertised so that patient’s quality of life is improved and so that data has integrity
What about “statistical analysis” and all of that research stuff:
- Pharmacology company is responsible for collecting, analyzing, and reporting data to FDA
- Her job is to provide patient care, nursing care, and advocacy
- Pharm company takes care of the statistical analysis
In the late 90s a seizure medicine came to market and was in the testing phase
- Managed seizure symptoms very well
- Caused acute liver failure
- “Hard Day” when the medicine was pulled by the FDA and Debbie and her team had to pull charts of patients taking this drug so as to call them and tell them to stop taking the medicine
Clinical Research Nurse, Norton Cardiovascular Associates
Main takeaway: we take care of the WHOLE patient; this is holistic care “I remember you. You get things done for me.” That’s what nurses do: we get things done for patients – communicate with MDs, open doors that patients can’t get through themselves.
What does job entail:
- 90% of the time: coordinating clinical research trials
- Work with pharma companies (Merck / Pfizer)
- Main goal is to help demonstrate that drugs are safe and improve quality of patient’s life – allows drugs to be approved by FDA
- Some of the drugs she’s worked with: beta blockers in heart failure, clot reducing drugs for patients with acute MI, anti-coagulant therapy for prevention of hear attacks
- Following protocols:
- Following FDA laws & regulations (consents, informed, educated, ethics)
- Spend lots of time with patients
- More time to spend with patients completing assessments, explaining lab work, educating patient on taking medications, what the medicines are doing
- During study visit: assessment, lab draws and explanations, follow up with problems
- Follow same patient for months, sometimes years
- Story: patient had symptoms (wife would state patient would stop breathing during sleep; didn’t have anything to do with current study, but she supplied him with a sleep study referral. One month later patient reported how great he felt and how grateful he was for her referral.
- Patients will often ask for ideas on how to manage health or other health related questions. She follows up. (“Who is the best lung doctor?)
- Great teamwork environment: work closely with doctors & nurse practioners. She is the “eyes and the ears” of the providers, supplying them with information critical for patient care.
- Works closely with patients
- Reminds them to come in for their visits
- Follows up with lab results and educations
- Manages care of patient in study specifically for cardiology (in this case)
- Ensures meds are being taken
- Educate patients on what labs results mean (this is your kidney function, etc.)
- Supplies prescribed drugs for those who need them
- Catches health issues that patient might not identify
- Story: patient needed Lipitor prior to entry into study. Prescribed by MD but couldn’t afford. She supplied coupon; coupon lost; pt paid for drug from grocery money; she went to pharmacy, provided coupon, pharmacist refunded money to patient. Patient was so grateful.
- Communication with care providers not involved in the study:
- What drugs patients are on and what they can expect
- Lab results (sometimes q 3 months – a great benefit for outside providers)
- She currently has a two year degree (grandfathered in) but current requirements are BSN or MSN
- She worked at Jewish in their Cardiac stepdown unit; 4 – 6 patients who were valve replacement or other cardiac post-op pts.
- She has always been interested in prevention: preventing patients from having cardiac procedures
- After rounding with a physician (she did this with all physicians as much as possible) he offered her a research job because he saw her interest in the whole patient
- She received on the job training; NHC offers the GEAR program for formal training
- Her suggestion for those interested: have a good background in the area of research you want to enter: cardiac nurses: cardiac research; ortho nurses, ortho research. Etc.
- Job has allowed her to work with patients and drug therapies that have prevented patients from having heart problems.
What do you need to do this job:
- Be assertive.
- Have to communicate clearly and in a timely manner to MDs and sometimes to providers in critical situations (as in during PT ED visits). “You have to know how to talk to people.”
- “If you are timid, you won’t survive in this profession!”
Specific programs she’s worked on:
- Merit study: beta blockers – help heart failure patients – improves left ventricular function
- Companion study – bi-ventricular pacing – cardiac resynchronization therapy (CRT)
- Cholesterol “statin” studies
- Retavase drug – clot reducing drug for MI patients
- Story: patient was given bolus of retavase at Suburban then transferred to Audobon’s cath lab. EMS forgot to take the infusion with them; she drove over to Audubon and ran “like a crazy person” to their cath lab to get the patient the drug he needed
How do you explain the “research” part of your job
- Drug companies have their own team of biostatisticians, so Clinical Research Nurse does not have to work with statistics
- Follow protocols – nurses are used to doing this. Follow the written rules for the study and provide patient care
- Paperwork is being transitioned to computer – familiarity with MS Word and email, and enter patient visit information into drug company online database
- Drug company monitors and double checks information entered into database – flags things that are unusual for the CRN to review
- Make sure the care provided is safe, holistic, and accurate, and data provided to drug company is accurate
- Follow drug protocols – including screeing, monitorin other meds patient is taking for interactions with this drug
She likes her job because she works week days, is able to set her hours and there are no weekends. Her other job is as a clinical research monitor.
- Audits research studies. Checks records, reviews consents, ensures assessments are being done
- Is a certified job
- Requires LOTS of travel