Job Summary
The Senior Clinical Research Associate in Psychiatry will be responsible for leading and overseeing clinical trial operations specifically in the mental health sector. This role is designed for an experienced professional who can work remotely from the West Coast, contributing to the advancement of psychiatric research through effective management of clinical studies.
Responsibilities
- Manage and supervise all phases of clinical trials with a focus on psychiatric studies.
- Ensure compliance with regulatory standards and company policies throughout the trial process.
- Collaborate with cross-functional teams to facilitate smooth project execution.
- Conduct site selection, initiation, monitoring, and closeout visits.
- Provide training and guidance to site staff on study protocols.
- Review and validate data collected from clinical trials, ensuring accuracy and adherence to regulatory requirements.
- Assist in the preparation of study reports and documentation for regulatory authorities.
- Support in the planning and execution of study-related meetings and presentations.
Qualifications
- Bachelor’s degree in a related field; advanced degree preferred.
- A minimum of 5 years of experience in clinical research, particularly in psychiatry or related specialties.
- Thorough understanding of GCP, ICH guidelines, and regulatory requirements.
- Strong analytical skills and attention to detail, with the ability to manage multiple priorities.
- Excellent communication and organizational skills, capable of working collaboratively in a remote environment.
- Proficiency in clinical trial management systems and related software.
