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Job Title: Clinical Site Monitor
Department: Clinical Affairs
Reporting To: Clinical Trials Manager
JOB SUMMARY
The Clinical Site Monitor is responsible for assurance of clinical trial site regulatory compliance and quality of clinical trial data via query resolution an on-site source data verification. This person is also responsible for site close-out activities.
DUTIES AND RESPONSIBILITIES
Participates in clinical site selection, qualification, initiation, activation and close-out activities
Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigational sites
Conducts interim monitoring visits on-site and remotely to complete clinical site and data monitoring and associated monitoring visit reports
Evaluates clinical data and coordinates data query resolutions
Performs source data verification
Required travel to investigative sites up to 75%
REPORTING
This position will report to the Adagio Medical Clinical Trials Manager.
JOB QUALIFICATION REQUIREMENTS
· >1.5 years field-based clinical trial monitoring experience or equivalent experience in clinical trials project management
· Experience with electronic data capture (EDC) applications, knowledge of key areas of Compliance
· Strong understanding of Good Clinical Practice (GCP), Good Documentation Practice (GDP) and FDA Code of Federal Regulations (GCP certification required)
· Strong communication skills as single point of contact for investigator
· Excellent organizational skills with high attention to detail
· Ability to manage, prioritize, and routinely report progress on projects and tasks
· Skilled in building and maintaining relationships with investigational sites