Job Summary
The Senior Clinical Research Associate (Sr. CRA) plays a pivotal role in the management and execution of clinical trials across the West Coast region of the United States. This position focuses on ensuring the adherence to protocols and regulatory standards while supporting clinical study operations. The Sr. CRA will also act as a liaison between sponsors and investigative sites, enhancing collaboration and communication to facilitate successful study outcomes.
Responsibilities
- Oversee monitoring activities at clinical trial sites to ensure compliance with study protocols and regulatory requirements.
- Maintain close collaboration with site staff and investigators to provide guidance and support throughout the study lifecycle.
- Prepare and manage monitoring reports, highlighting any issues and implementing corrective actions when necessary.
- Provide training and support to junior CRAs and site personnel regarding study procedures and documentation.
- Assist in the preparation of study-related materials such as protocols and informed consent forms.
- Ensure the timely collection and review of data and documentation from clinical sites.
Qualifications
- A bachelor’s degree in life sciences or a related field is required; advanced degrees are a plus.
- Significant experience in clinical research, including prior roles as a CRA, with a solid understanding of clinical trial regulations.
- Strong organizational skills and attention to detail, along with effective communication abilities.
- Proficient in utilizing clinical trial management systems and electronic data capture tools.
- Ability to work independently and collaboratively within a team-oriented environment.
