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Clinical Research Professional
hace 1 semana
At ICON, we're seeking a skilled Clinical Research Associate 2 to join our team. This role is 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- Complete onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes.
- Verify the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
- Ensure the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
- Write and submit reports of investigational site findings and updates applicable tracking systems. Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate.
- Participate in audit preparation and follow-up activities as needed.
- May serve as preceptor, providing training to less experienced clinical team members.
Required Skills and Qualifications
- Bachelor's degree in a health, life sciences or medical field.
- At least 1 year of experience with on-site monitoring, preferably with oncology protocols.
- Full availability to travel.
- Fluent in English and Spanish (read, write and speak).
- Must be based in CABA.
