
Dedicated CRA Specialist
2 days ago
At the heart of our clinical trials are dedicated professionals who ensure that research is conducted in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
Clinical Research Associates (CRAs) play a pivotal role in this process, conducting on-site and remote monitoring to guarantee compliance.
Key responsibilities include:
- Conducting on-site and remote monitoring to verify adherence to GCP guidelines and regulatory stipulations.
- Designing and implementing tools, procedures, and processes to ensure quality monitoring, such as developing monitoring plans, checklists, and templates.
- Collaborating with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to facilitate smooth study conduct.
- Maintaining accurate and timely documentation of monitoring activities and findings, including drafting monitoring reports, follow-up letters, and action plans.
- Bachelor's degree in a related field or equivalent experience.
- Minimum of 2-4 years of experience in clinical research monitoring.
- Thorough knowledge of GCP guidelines and regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to work independently and manage multiple priorities effectively.
While certification is not mandatory, possessing a Certified Clinical Research Associate (CCRA) credential or equivalent is preferred.
Necessary skills for success include:
- Attention to detail and strong analytical capabilities.
- Problem-solving abilities and critical thinking.
- Effective team collaboration and interpersonal communication.
- Strong organizational and time management skills.
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