Job Summary
The Senior Clinical Research Associate (Senior CRA) plays a pivotal role in overseeing clinical trials to ensure compliance with regulatory requirements and the ethical conduct of research. This position involves interacting with various stakeholders including clinical sites and sponsors while ensuring the integrity of study data and adherence to protocols.
Responsibilities
- Lead and manage the monitoring activities of clinical trials from initiation through completion.
- Conduct site visits to monitor progress, ensure adherence to protocol, and verify data accuracy.
- Assist in the selection, initiation, and training of clinical sites and staff.
- Collaborate with the study team to resolve issues and ensure timely completion of projects.
- Prepare and review study documentation, including reports and regulatory submissions.
- Ensure compliance with Good Clinical Practice (GCP) and applicable regulations.
- Support the process of audit and inspection readiness activities.
Qualifications
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- Proven experience in clinical research, specifically as a CRA, with a deep understanding of clinical trial processes.
- Exceptional organizational and communication skills.
- Ability to work both independently and as part of a collaborative team.
- Keen attention to detail and strong analytical skills.
- Familiarity with electronic data capture systems and clinical trial management software.
