Clinical Study Associate
Há 1 mês
Syneos Health is seeking a highly skilled Clinical Study Associate to join our team. As a Clinical Study Associate, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities and close-out visits. You will ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Key Responsibilities:- Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits.
- Ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- 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.
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- 2 years (or more) of experience as Clinical Research Associate.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation and interpersonal skills.
Syneos Health is a leading biopharmaceutical solutions organization built to accelerate customer success. We are seeking a Site Management Associate to join our team. As a Site Management Associate, you will be responsible for site support throughout the study lifecycle from site identification through close-out.
Key Responsibilities:- Site support throughout the study lifecycle from site identification through close-out.
- Knowledge of local requirements for real world late phase study designs.
- Chart abstraction activities and data collection.
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff.
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- 2 years (or more) of experience as Clinical Research Associate.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation and interpersonal skills.
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