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Title
Text copied to clipboard!Clinical Research Associate
Description
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We are looking for a dedicated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team. The CRA will be responsible for overseeing and managing clinical trials, ensuring that they are conducted in compliance with regulatory standards and company policies. This role involves close collaboration with clinical investigators, site staff, and other stakeholders to ensure the integrity and quality of clinical data. The ideal candidate will have a strong background in clinical research, excellent organizational skills, and the ability to work independently as well as part of a team. Key responsibilities include monitoring clinical trial sites, ensuring adherence to study protocols, and maintaining accurate and comprehensive documentation. The CRA will also be responsible for identifying and resolving issues that may arise during the course of the study, providing training and support to site staff, and ensuring that all activities are conducted in accordance with Good Clinical Practice (GCP) guidelines. This position requires frequent travel to clinical sites, strong communication skills, and the ability to manage multiple tasks simultaneously. The successful candidate will be proactive, detail-oriented, and committed to maintaining the highest standards of quality and compliance in clinical research.
Responsibilities
Text copied to clipboard!- Monitor clinical trial sites to ensure compliance with study protocols and regulatory requirements.
- Conduct site initiation, routine monitoring, and close-out visits.
- Ensure accurate and timely documentation of all trial-related activities.
- Collaborate with clinical investigators and site staff to resolve issues and ensure data integrity.
- Provide training and support to site staff on study procedures and GCP guidelines.
- Review and verify case report forms (CRFs) for accuracy and completeness.
- Ensure proper storage and handling of investigational products.
- Prepare and submit regulatory documents and reports.
- Maintain effective communication with study sponsors and other stakeholders.
- Identify and escalate issues that may impact the quality or integrity of the study.
- Participate in the development and review of study protocols and other trial-related documents.
- Ensure compliance with all applicable regulatory requirements and company policies.
- Assist in the preparation and conduct of audits and inspections.
- Maintain up-to-date knowledge of industry trends and best practices.
- Contribute to the continuous improvement of clinical research processes and procedures.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, nursing, or a related field.
- Minimum of 2 years of experience in clinical research or a related field.
- Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Excellent organizational and time management skills.
- Strong attention to detail and accuracy.
- Ability to work independently and as part of a team.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office and clinical trial management systems (CTMS).
- Ability to travel frequently to clinical sites.
- Strong problem-solving and critical-thinking skills.
- Ability to manage multiple tasks and priorities simultaneously.
- Experience with electronic data capture (EDC) systems is preferred.
- Certification as a Clinical Research Associate (CCRA) is a plus.
- Knowledge of medical terminology and clinical trial processes.
- Ability to maintain confidentiality and handle sensitive information.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with monitoring clinical trial sites?
- How do you ensure compliance with GCP guidelines and regulatory requirements?
- What strategies do you use to manage multiple tasks and priorities?
- Can you provide an example of a challenging issue you encountered during a clinical trial and how you resolved it?
- How do you maintain effective communication with clinical investigators and site staff?
- What experience do you have with electronic data capture (EDC) systems?
- How do you ensure the accuracy and completeness of case report forms (CRFs)?
- Can you describe your experience with preparing and submitting regulatory documents?
- What steps do you take to stay up-to-date with industry trends and best practices?
- How do you handle frequent travel and manage your time effectively?
