Job Summary
The Clinical Research Associate II plays a vital role in the clinical trial process, responsible for overseeing the progression of study projects. This position involves ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the research lifecycle.
Responsibilities
- Conduct site visits to monitor the execution of clinical trials and ensure adherence to protocol guidelines.
- Evaluate trial documentation and report on study progress, identifying any irregularities.
- Facilitate communication between study sites and the sponsor, addressing inquiries and providing necessary support.
- Assist in the training and education of site staff on study protocols and processes.
- Contribute to the preparation and submission of study-related documents to regulatory authorities.
Qualifications
- Bachelor’s degree in a relevant scientific or healthcare field.
- Previous experience in clinical research, preferably as a Clinical Research Associate.
- Strong knowledge of Good Clinical Practice (GCP) and regulatory standards.
- Excellent organizational and communication skills, with the ability to work independently.
- Proficiency in managing multiple priorities and meeting deadlines effectively.
The Emmes Company, LLC 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.
