Sr. Clinical Research Associate Job Description Template
The Sr. Clinical Research Associate (CRA) is responsible for planning, coordinating, and overseeing clinical trials. This role ensures that clinical studies are conducted in compliance with regulatory requirements and company SOPs, and that they meet necessary quality standards. The Sr. CRA will work closely with clinical sites, investigators, and internal teams to drive the success of research projects.
Responsibilities
- Oversee the execution of clinical trials in accordance with GCP, ICH guidelines, and regulatory requirements.
- Monitor clinical sites to ensure compliance with study protocols.
- Perform site selection, initiation, monitoring, and close-out visits.
- Ensure accurate documentation of all study-related activities.
- Facilitate communication between the study sponsor, investigators, and clinical sites.
- Report and resolve any issues related to study conduct and patient safety.
- Review and verify case report forms and source documents for accuracy and completeness.
- Assist in the preparation of clinical trial reports and regulatory submissions.
Qualifications
- Bachelor’s degree in life sciences, nursing, or a related field.
- Minimum of 5 years of experience in clinical research, with a focus on clinical trials.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Strong organizational and project management skills.
- Excellent communication and interpersonal skills.
- Ability to travel as required.
Skills
- Clinical trial management
- Good Clinical Practice (GCP)
- ICH guidelines
- Regulatory compliance
- Project management
- Data analysis
- Report writing
- Communication
- Problem-solving
Frequently Asked Questions
A Senior Clinical Research Associate (Sr. CRA) plays a critical role in managing clinical trials to test new pharmaceuticals or treatments. They ensure that trials adhere to regulatory and ethical standards while monitoring study progress, analyzing data, and reporting findings. Sr. CRAs work closely with clinical trial sites to ensure compliance and manage study protocols effectively.
To become a Senior Clinical Research Associate, a candidate typically needs a bachelor’s degree in life sciences, nursing, or a related field, along with several years of experience in clinical research. Advanced positions may require a master’s degree or certification, such as a Certified Clinical Research Professional (CCRP). Gaining experience in clinical trials and project management is essential for advancement.
The average salary for a Senior Clinical Research Associate varies depending on location, experience, and industry. Sr. CRAs working in large pharmaceutical companies or cities with high living costs may earn more. Salary is typically competitive, reflecting the advanced oversight and expertise required to manage clinical trials effectively, ensuring compliance and driving innovation.
Qualifications for a Senior Clinical Research Associate include a bachelor’s degree in health sciences, biology, or a related field. Many roles require experience in clinical trials, knowledge of regulatory requirements like GCP, and certifications such as CCRP or ACRP. Skills in project management, attention to detail, and strong communication abilities are vital to succeed in this role.
A Senior Clinical Research Associate must possess excellent analytical skills, attention to detail, and problem-solving abilities. They are responsible for designing study protocols, ensuring regulatory compliance, and managing timelines. Effective communication with multidisciplinary teams and maintaining ethical standards are crucial. Experience with trial management systems and data analysis tools is often necessary.