Clinical Research Associate (CRA)
Clinical Research Associate (CRA)
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Clinical Research Associate (CRA)
- Summary:
We are helping our client to seeking a highly motivated and detail-oriented individual as a Clinical Research Associate (CRA). The CRA will play a crucial role in the execution and management of clinical trials, ensuring compliance with protocols, regulations, and company procedures. The ideal candidate will have strong communication skills, exceptional organizational abilities, and a passion for contributing to the advancement of medical research.
- Responsibilities:
- Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with applicable regulations, guidelines, and standard operating procedures (SOPs).
- Review and evaluate clinical data and source documents to ensure accuracy, completeness, and compliance with study protocols and regulatory requirements.
- Maintain regular communication with investigative site staff to provide guidance on protocol requirements, study procedures, and data collection.
- Monitor subject safety throughout the duration of the trial, including adverse event reporting and resolution.
- Perform site document management, including tracking and filing essential regulatory documents, contracts, and study-related correspondence.
- Ensure that investigational product (IP) accountability procedures are followed and that IP is appropriately handled, stored, and dispensed at investigational sites.
- Assist with the development and review of study-related documents, including study protocols, informed consent forms, case report forms, and clinical study reports.
- Participate in study team meetings and conference calls, providing updates on site monitoring activities, protocol deviations, and other relevant issues.
- Contribute to the identification and resolution of clinical trial-related problems and challenges.
- Assist with the training of investigational site staff on study protocols, procedures, and regulatory requirements.
Qualifications:
- Bachelor's degree in a scientific or healthcare-related field (Master's degree preferred).
- Minimum of 2 years of experience as a Clinical Research Associate or equivalent experience in clinical research.
- Strong understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and ICH guidelines.
- Proficiency in clinical trial monitoring techniques, including source data verification and query resolution.
- Excellent communication and interpersonal skills, with the ability to effectively interact with investigational site staff, study team members, and external stakeholders.
- Demonstrated ability to manage multiple tasks simultaneously and prioritize workload effectively.
- Detail-oriented with strong organizational skills and the ability to maintain accurate and thorough documentation.
- Proficiency in Microsoft Office applications and electronic data capture systems.
- Willingness to travel domestically and internationally as needed (up to 50% travel may be required).
- Certification as a Clinical Research Associate (CCRA) or equivalent certification preferred.