Job Duties and Responsibilities: Provides support to Project Team and Clinical Operations Team. Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects. Demonstrates strong written and verbal communication skills. Serves as primary contact for assigned research sites. Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period. Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines. Verifies the rights and well-being of trial subjects are protected. Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
Education: 4 year college graduate, preferably with a healthcare or life science degree. In lieu of a degree, candidates with 3 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
Experience: Minimum of 3 years of experience in on-site monitoring of clinical studies. Monitoring experiences in several different indications and study types. Experience in all areas of monitoring (on-site, remote, etc.)
Skills/Competencies: Strong written and verbal communication skills. Strong interpersonal skills. Expert monitoring skills to independently conduct all types of site monitoring visits. Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding). Strong computer skills, including Microsoft Office
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