• 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:

1. Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with applicable regulations, guidelines, and standard operating procedures (SOPs).
2. Review and evaluate clinical data and source documents to ensure accuracy, completeness, and compliance with study protocols and regulatory requirements.
3. Maintain regular communication with investigative site staff to provide guidance on protocol requirements, study procedures, and data collection.
4. Monitor subject safety throughout the duration of the trial, including adverse event reporting and resolution.
5. Perform site document management, including tracking and filing essential regulatory documents, contracts, and study-related correspondence.
6. Ensure that investigational product (IP) accountability procedures are followed and that IP is appropriately handled, stored, and dispensed at investigational sites.
7. Assist with the development and review of study-related documents, including study protocols, informed consent forms, case report forms, and clinical study reports.
8. Participate in study team meetings and conference calls, providing updates on site monitoring activities, protocol deviations, and other relevant issues.
9. Contribute to the identification and resolution of clinical trial-related problems and challenges.
10. Assist with the training of investigational site staff on study protocols, procedures, and regulatory requirements.

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Qualifications:

1. Bachelor's degree in a scientific or healthcare-related field (Master's degree preferred).
2. Minimum of 2 years of experience as a Clinical Research Associate or equivalent experience in clinical research.
3. Strong understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and ICH guidelines.
4. Proficiency in clinical trial monitoring techniques, including source data verification and query resolution.
5. Excellent communication and interpersonal skills, with the ability to effectively interact with investigational site staff, study team members, and external stakeholders.
6. Demonstrated ability to manage multiple tasks simultaneously and prioritize workload effectively.
7. Detail-oriented with strong organizational skills and the ability to maintain accurate and thorough documentation.
8. Proficiency in Microsoft Office applications and electronic data capture systems.
9. Willingness to travel domestically and internationally as needed (up to 50% travel may be required).
10. Certification as a Clinical Research Associate (CCRA) or equivalent certification preferred.