Life Science
A company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis
What is a CRO?
Clinical trial tests the safety, side effects, best dose, and timing of a new treatment.
What is Phase 1 study?
Supports day to day trial activities. Ensures all documents are accurate and updated. This is an entry level role within clinical operations.
Who is a Clinical Trial Associate (CTA)?
1 hour talk time
What is phone call?
Coordinate the essential documentation and resources required for the filing of global applications.
What is regulatory?
Astellas, BMS, Sanofi, Merck, AbbVie, Abbott are all examples of this
What are examples of a Sponsor company?
Once it is established that there are no major safety concerns, an agent is further tested to see whether it still appears safe in a larger cohort of people (typically 50-500) with the disease under study.
What is phase 2 study?
Field based monitor. They travel to clinical research sites to ensure the trial is running correctly.
Who is a Regional Clinical Research Associate (CRA)?
1 -2 per week after week 8 and 3 per week after 12 weeks
What are submittals to hiring manager goals?
Ensure that the medication being manufactured will provide the desired effect to the patient. Also guarantees that there are no contaminants present and that the medications will meet requirements and all relevant regulations.
What is quality?
Develop products using live material, such as cells to solve various issues.
What is a biotechnology company?
Determine whether the experimental agent is effective in a still larger population, typically several hundred to several thousand. These trials usually last at least a couple of years, and often considerably longer.
What is phase 3 study?
Execute and supervise clinical trials. Ensures studies are complete within budget and highest quality.
Who is a CTM/Clinical Project Manager?
2-3 per week after week 4
What are the leads goals?
Responsible for designing, planning, and physically running clinical trials throughout all phases.
What is clinical operations team?
Develops surgical instruments to diagnose, treat, or prevent various medical conditions. Examples: pacemakers, ventilators, stents, and artificial joints.
What is a medical device company?
After a drug has been approved and is on the market, additional studies are done to see how well it works under "real world" conditions and to determine whether its efficacy is durable, or long-lasting. Importantly, post-marketing studies also look for uncommon or long-term toxicities that did not show up in earlier trials
What is Phase 4 study?
Collection of trials that are testing the same drug, but this could also be a collection of trials within the same therapeutic area. This person develops budgets, risks, resources for each clinical trial. They also help create clinical development plans, study protocol and leads clinical development.
Who is a Clinical Program Manager?
5 per week
What is resumes/quality of database add per week?
Referred to as Safety Pharmacology or Pharmacovigilance, is a critical pre-clinical step in the drug development process
What is drug safety?
Is a commercial business licensed to research, develop, market and/or distribute drugs
What is a pharmaceutical company?
Series of test scientist conduct for new drugs, new medical procedures, or new devices.
What are clinical trials?
Ensure that the rights and well-being of the study participants are protected, the quality and integrity of the data is maintained, and all study files and conduct of trial follow the currently approved protocol, GCP, and all applicable regulatory requirements.
What is site monitoring?
Recruiter must maintain a relationship with the candidate in a certain time frame
What is 60-day ownership?
Informed consent, study protocol, reporting adverse events, study visits, subject compensation, study closeout.
What is running a study?