Our Clinical Research Associate job description includes the responsibilities, duties, skills, education, qualifications, and experience.
About the Clinical Research Associate role
A Clinical Research Associate (CRA) is responsible for monitoring the progress of clinical trials, ensuring they are conducted in compliance with protocol, regulatory requirements, and Good Clinical Practices (GCPs). CRAs also review and evaluate data collected during studies, report findings, and provide feedback to the sponsor organization.
Role Purpose
The purpose of a Clinical Research Associate (CRA) is to monitor, coordinate, and manage the clinical research studies of pharmaceutical, biotechnology, and medical device companies. The CRA is responsible for ensuring that clinical trial protocols are followed, and that data is accurately collected and reported. The CRA works with investigators, researchers, and other clinical staff to ensure compliance with ethical and regulatory standards, and to ensure the safety of the research subjects. CRA’s also review and analyze data, prepare reports, and participate in meetings with regulatory agencies.
Clinical Research Associate Summary
Clinical Research Associate Job Summary:
The Clinical Research Associate (CRA) is responsible for the coordination, execution, and management of clinical trials. The CRA will work with the Clinical Research Manager to ensure that clinical trials are conducted according to applicable regulations and Good Clinical Practices. The CRA will be responsible for monitoring study sites, ensuring adherence to study protocols, reviewing and tracking source documents, and reporting findings to the Clinical Research Manager. The position requires excellent organizational skills, attention to detail, and the ability to work independently.
Clinical Research Associate Duties
- Develop and maintain study protocols and case report forms
- Conduct site selection, initiation, monitoring and close-out visits
- Review and query data to ensure accuracy, completeness and consistency
- Review and track regulatory documents
- Assist in the preparation and submission of clinical study reports
Clinical Research Associate Skills
- Strong organizational skills
- Excellent communication skills
- Strong attention to detail
- Knowledge of clinical trial protocols and regulations
Clinical Research Associate Requirements
- Bachelor's degree in clinical research, life sciences or related field
- Thorough knowledge of clinical research protocols, processes and regulations
- Ability to coordinate multiple tasks simultaneously
- Strong organizational, interpersonal and communication skills
- Ability to work both independently and as part of a team
Personal Traits
- Strong analytical skills
- Attention to detail
- Ability to work independently
- Excellent communication and interpersonal skills