SUMMARY
The Research Assistant (RA) is responsible for assisting with document management, protocol related clinical assessments of research subjects, laboratory functions and assisting in tasks related to the work of the Clinical Research Coordinators.
REQUIREMENTS
The position of RA requires at least a high school diploma or equivalent, but individuals with college degrees or advanced degrees are preferred. The RA must possess excellent clerical skills, good interpersonal skills, and must be able to provide accurate documentation of his or her work. The clinical research assistant must be willing to learn and be able to develop proficiency at clinical skills including phlebotomy, vital sign measurements, and performing ECGs under the preceptor ship of a research clinician or experienced research technician. Previous experience or knowledge of such clinical skills is preferred.
RESPONSIBILITIES
The activities of the RA include, but are not limited to:
- Entering subject information into one or more databases
- Maintenance of database information
- Assisting in subject visits, including direct contact with subjects, processing of visit data, ensuring the completeness and integrity of source documents and case report forms (CRFs), and other related duties.
- Preparation for office/laboratory visits (i.e., “set-up”)
- Reading and understanding study protocols
- Participation in a clinical preceptor ship whereby training in clinical skills will be provided by a research clinician or experienced technician. Clinical skills which will be expected after training include phlebotomy, vital sign measurement, performing ECGs, and assessment of general health.
- Performing clinical assessments of study subjects as per protocol, as delegated by PI, and under the direct supervision of a licensed clinician. These assessments include, but are not limited to, collecting VS, performing ECG and venipuncture, etc.
- All work is done in accordance with Good Clinical Practices (GCPs), Corporate Standard Operating Procedures (SOPs), and principles set forth in the CFR 21 and ICH guidelines.
Without drugs, physicians would struggle to find relevance, and patients would suffer without hope.
I must say, I spend a lot of my time these days trying to persuade people that controlled trials are the only way to get information that’s reliable about drugs.
It is easy to get a thousand prescriptions, but hard to get one single remedy.
The greatest joy in life is to accomplish. It is the getting, not the having. It is the giving, not the keeping.
One sometimes finds what one is not looking for.
If you think compliance is expensive, try non-compliance.
I am not accustomed to saying anything with certainty after only one or two observations.
Let me tell you the secret that has led me to my goal. My strength lies solely in my tenacity.
Advances in drug development have led to greater improvement in the quality of human life than advances in all other fields combined.
The pace of discovery is going unbelievably fast.
The reward for work well done is the opportunity to do more.
I have no ideology. My ideology is health.
Drugs don’t work in patients who don’t take them.
Remember the Three Princes of Serendip who went out looking for treasure? They didn’t find what they were looking for, but they kept finding things just as valuable. That’s serendipity, and our business [drugs] is full of it.
The cures we want aren’t going to fall from the sky. We have to get ladders and climb up and get them.
Good information is the best medicine.
One never notices what has been done; one can only see what remains to be done.
All truths are easy to understand once they are discovered; the point is to discover them.
The best way to predict the future is to invent it.
I trust I may be enabled in the treatment of patients always to act with a single eye to their good.
There is so much more to be done; the patients are waiting.