Job Summary
The Senior Clinical Research Associate for Metabolic studies plays a critical role in the oversight and management of clinical trials related to metabolic health. This position is essential for ensuring the adherence to regulatory standards and protocols while delivering high-quality research outcomes. The Senior CRA will function as a pivotal link between the site-based teams and project management, ensuring that studies are conducted efficiently and effectively.
Responsibilities
- Manage the planning, execution, and closing of clinical trials while adhering to Good Clinical Practice (GCP) guidelines.
- Coordinate and perform site initiation, monitoring, and close-out visits to ensure compliance with clinical protocols.
- Review and verify trial data for accuracy and completeness while ensuring that all documentation is maintained properly.
- Provide training and support to site staff and assist in resolving any issues that arise during the study.
- Collaborate with cross-functional teams to facilitate the successful completion of studies.
- Engage in site selection and qualification activities to ensure optimal site performance.
- Prepare reports and communicate findings to stakeholders efficiently to support decision-making processes.
Qualifications
- Bachelor’s degree in a relevant scientific or clinical field; advanced degree is a plus.
- Significant experience as a Clinical Research Associate, preferably within the metabolic discipline.
- Comprehensive knowledge of ICH guidelines, GCP, and relevant regulatory requirements.
- Strong organizational skills and the ability to manage multiple tasks concurrently.
- Excellent verbal and written communication skills.
- Ability to work independently, as well as part of a collaborative team.
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.
