Job Summary
The Senior Clinical Research Associate (CRA) for CNS/Psychiatry will play a vital role in conducting and overseeing clinical trials within the fields of central nervous system disorders and psychiatric conditions. This position is specifically focused on the Northeast/Mid-Atlantic regions of the United States. The CRA will ensure compliance with regulatory standards and clinical protocols while managing and monitoring trial progress.
Responsibilities
- Lead the management and execution of clinical trials for CNS and psychiatric studies.
- Coordinate with various investigative sites to ensure adherence to study protocols and timelines.
- Monitor patient recruitment, data collection, and site performance throughout the trial.
- Prepare and maintain essential documentation, including study reports and regulatory submissions.
- Collaborate with cross-functional teams to facilitate effective trial management and communication.
- Provide training and support to site staff on trial protocols and procedures.
- Address and resolve any site-related issues, ensuring adherence to ethical standards.
Qualifications
- A minimum of 5 years of experience in clinical research, particularly within CNS or psychiatric studies.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements.
- Excellent organizational skills with the ability to manage multiple projects efficiently.
- Effective communication skills to liaise with diverse stakeholder groups.
- Ability to work independently and as a part of a collaborative team.
- A bachelor’s degree in a related scientific field; advanced degrees are preferred.
