Anna Jaques Hospital
Boston, MA
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. The Clinical Trials Monitor (CTM) monitors and audits the investigator-initiated clinical research studies across all disease groups in the Cancer Clinical Trials Office. The CTM will also help with audit prep by reviewing records for potential FDA or sponsor audits and may be involved in quality improvement and policy. The position is primarily remote but may require some on site work. Job Description: Essential Responsibilities: Monitors study facility to assure compliance with GCLP and ICH guidelines. (essential) Conducts detailed review of clinical studies in collaboration with pharmaceutical companies and other sponsors. (essential) Conducts audits of study facility including equipment, documents and procedures to ensure regulatory compliance. (essential) Manages Corrective Action Logs, Deviation Trending Logs, SOPs, GCLP Documents and...