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.
Worldwide Clinical Trials provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
