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Title
Text copied to clipboard!Clinical Research Associate
Description
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We are looking for a dedicated and meticulous Clinical Research Associate to join our healthcare team. The Clinical Research Associate will be responsible for leading and managing clinical trials to ensure adherence to protocols and overall clinical objectives. You will be tasked with monitoring clinical trials, working directly with the clinical research coordinator, and ensuring that all trial activities are carried out while adhering to regulatory standards and guidelines. Your role will involve direct clinical practice, research, and consultation, as well as education and administrative activities. You will also be responsible for ensuring that the design, conduct, and reporting of clinical trials comply with all applicable regulatory standards.
Responsibilities
Text copied to clipboard!- Designing and writing trial protocols.
- Presenting trial protocols to a steering committee.
- Setting up the study sites, ensuring each center has the trial materials.
- Monitoring the trial throughout its duration.
- Verifying that data entered onto the CRFs is consistent with patient clinical notes.
- Writing visit reports and filing and collating trial documentation and reports.
- Ensuring all unused trial supplies are accounted for.
- Closing down trial sites on completion of the trial.
- Discussing results with a medical statistician.
- Preparing final reports.
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences or related field.
- Proven experience as a Clinical Research Associate.
- Knowledge of FDA guidelines related to drug development and clinical trials.
- Excellent knowledge of medical terminology.
- Strong understanding of clinical trial design and testing.
- Excellent organizational and communication skills.
- A meticulous approach to documentation and procedures.
- Ability to multitask and work effectively in a fast-paced environment.
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel).
- Willingness to travel as necessary.
Potential interview questions
Text copied to clipboard!- What is your experience with clinical trial protocols?
- How do you ensure compliance with all regulatory standards?
- Can you describe a time when you had to manage a particularly challenging clinical trial?
- How do you handle documentation and reporting in your current role?
- What strategies do you use to manage your time and prioritize tasks during a clinical trial?