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Clinical Research Associate
hace 1 semana
At ICON, we are a leading provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Our commitment is to help our clients bring life-changing medicines to patients in need.
Job OverviewWe are seeking a highly motivated Clinical Research Associate 2 to join our team. As a Clinical Research Associate 2, you will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.
Main Responsibilities- Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes.
- Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
- Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
- writes and submits reports of investigational site findings and updates applicable tracking systems.
- Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
- Participates in audit preparation and follow-up activities as needed.
- MAY serve as preceptor, providing training to less experienced clinical team members.