Clinical Research Associate II
hace 4 semanas
Job Summary:
We are seeking a highly skilled Clinical Research Associate II to join our team at Pharmiweb. As a CRA II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
- Support subject/patient recruitment, retention, and awareness strategies.
- Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
Requirements:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
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