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.
