A Clinical Research Associate (CRA) is responsible for coordinating and monitoring the progress of clinical trials and other research studies. They work to ensure that the study is conducted in compliance with ethical standards and regulatory requirements, and that the study produces high-quality data that can be used to support the safety and efficacy of a drug or medical device.
Specific tasks and responsibilities of a Clinical Research Associate may include:
- Planning and managing the conduct of clinical trials
- Screening and enrolling patients in a study
- Ensuring that the study is conducted in accordance with the study protocol and the relevant regulations
- Monitoring the progress of the study at the investigative sites
- Reviewing and verifying data and case report forms
- Identifying and resolving any issues that arise during the study
- Preparing reports and other documentation related to the study
- Keeping track of regulatory documents, maintaining accurate records and ensuring that they are up to date
- Staying current on regulatory guidelines and industry developments
The requirements for a Clinical Research Associate position typically include a degree in a relevant field such as nursing, pharmacology, or a related field, and experience in a healthcare or research setting is highly desirable. Strong problem-solving skills and the ability to work well in a team environment are also important. Good organizational skills, attention to detail, and strong communication skills are also essential for this role.
Clinical Research Associates can progress to more senior roles such as Senior Clinical Research Associate, Project Manager, Clinical Operations Manager, Director of Clinical Research, etc. They can also pursue a career in related areas such as clinical data management, regulatory affairs or medical writing.
Other terms for this job-profile
Different job titles that could be used for Clinical Research Associate include Clinical Research Coordinator, Clinical Research Investigator, and Clinical Monitoring Associate.
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