Senior Cra
hace 6 días
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.
While projects vary, your typical responsibilities might include:
- Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
- 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
- You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.
**REQUIREMENTS**
You should have:
- 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.
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