Discover the essential requirements, duties, responsibilities, and skills needed for a Clinical Research Associate job description.
What does a Clinical Research Associate do?
A clinical research associate, also known as a CRA, is someone who oversees and manages clinical trials and studies for biotechnological and pharmaceutical products. Their main job is to make sure these products are safe and can be sold on the market.
Job Description
We are looking for an organized and flexible clinical research associate to supervise clinical trials. As a CRA, you will create protocols for the trials, choose where the trials will take place, train staff at these sites, and manage the materials needed for the trials. You will also be responsible for taking care of the subjects involved in the trials, visiting the sites regularly, and updating and distributing important information to internal and external parties. You will also be in charge of keeping track of all the documentation and records related to the trials.
To be successful in this role, you should be able to identify and solve problems quickly. You should also pay attention to detail, be able to handle multiple tasks at once, and work well with others.
Job Duties and Responsibilities
- Create and write protocols for the trials and present them to the steering committee.
- Select, evaluate, and establish trial sites, and close them down when the trials are finished.
- Train staff at the sites on the specific therapy areas, protocol requirements, and proper documentation.
- Communicate with the ethics committee to ensure the safety and well-being of the subjects involved in the trials.
- Order, track, and manage materials needed for the trials.
- Keep track of and document the inventory and distribution of the materials.
- Protect the confidentiality of the subjects, update their information, and make sure the materials are used according to the protocol.
- Visit the trial sites regularly, hold project meetings, and write reports about the visits.
- Take action if a site is not meeting expectations.
- Communicate with regulatory authorities.
- Make sure all procedures and regulations are being followed, including SOPs, local regulations, ICH (International Council for Harmonisation) guidelines, and GCP (Good Clinical Practice) guidelines.
- Perform any other tasks and responsibilities as needed.
Requirements and Qualifications
- Bachelor's degree in a biological science or a related field.
- At least 2 years of experience as a clinical research associate.
- Knowledge of the pharmaceutical industry, including terminology and practices.
- Understanding of FDA regulations and how they are applied in real-life situations.
- Strong verbal and written communication skills.
- Proficient computer skills.
- Familiarity with Microsoft Office programs such as Word, Excel, and PowerPoint.
- Ability to manage and prioritize a heavy workload efficiently.
- Willingness to travel frequently and at short notice, and the ability to manage travel schedules.
- A valid driver's license, good driving skills, access to reliable transportation, and up-to-date car insurance.
Clinical Research Associate Salary
The earning potential of a Clinical Research Associate can vary significantly based on factors such as geographic location, industry, professional experience, educational background, and the specific employer. On average, the annual salary for an Clinical Research Associate in the United States is approximately $80780.
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