CRA II Oncology Specialist
hace 2 días
Join Syneos Health, a leading fully integrated biopharmaceutical solutions organization, as a CRA II Oncology Specialist. In this role, 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.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assess site processes, conduct Source Document Review of appropriate site source documents and medical records, verify required clinical data entered in the case report form (CRF) is accurate and complete, apply query resolution techniques remotely and on site, and verify site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- 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.
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CRA II Oncology Specialist
hace 3 días
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoJob Title: CRA II Oncology SpecialistSyneos Health, Inc. is seeking a highly skilled CRA II Oncology Specialist to join our team. As a CRA II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and closeout visits to ensure regulatory, ICH-GCP, and protocol compliance.Key...
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CRA II Oncology Specialist
hace 2 días
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoJob Title: CRA II Oncology SpecialistSyneos Health, Inc. is seeking a highly skilled CRA II Oncology Specialist to join our team. As a CRA II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and closeout visits to ensure regulatory, ICH-GCP, and protocol compliance.Key...
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CRA II Position in Oncology
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Madrid, Madrid, España Syneos Health, Inc. A tiempo completoJob Title: CRA II Position in OncologyWe are seeking a highly skilled CRA II to join our team in Madrid, Spain. 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...
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