Job Summary
The Senior Clinical Research Associate is responsible for overseeing and coordinating clinical trials, focusing specifically on Central Nervous System (CNS) studies in the Southeast and Mid-Atlantic regions of the United States. This role plays a critical part in ensuring the successful execution of clinical studies while adhering to regulatory compliance and maintaining high-quality data collection and reporting.
Responsibilities
- Manage the entire lifecycle of clinical trials, ensuring compliance with protocols and regulatory requirements.
- Monitor study sites to assess compliance with Good Clinical Practices (GCP) and study protocols.
- Collaborate with cross-functional teams to facilitate smooth execution of clinical trials.
- Provide training and support to site staff on study protocols and procedures.
- Conduct site selection, initiation, monitoring, and close-out visits.
- Collect and review clinical data for accuracy and completeness.
- Prepare reports and provide updates to stakeholders regarding trial progress.
Qualifications
- Bachelor’s degree in life sciences or a related field; advanced degrees are a plus.
- A minimum of 3-5 years of experience in clinical research, particularly in CNS trials.
- Comprehensive understanding of GCP, ICH guidelines, and regulatory requirements.
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities.
- Excellent communication and interpersonal skills for effective collaboration with site staff and investigators.
