Description
The Senior Clinical Research Associate (CRA) will play a crucial role in the planning, execution, and management of clinical trials. This position requires a highly skilled and experienced professional who can ensure the integrity of clinical data, compliance with regulatory requirements, and the overall success of clinical research projects.
Typical responsibilities include:
- Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
- Supporting the development of a subject recruitment plan
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites
- Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
Requirements:
- A Bachelor's degree in a health care or other scientific discipline or educational equivalent
- At least 4 years of on-site monitoring experience
- Advanced in English
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements
- Strong organizational and time management skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems
- Willingness to travel as required