JOB TITLE: Clinical Site Monitor
DEPARTMENT: Clinical Affairs
REPORTS 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
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Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
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Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigational sites
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Conducts interim monitoring visits on-site and remotely to complete clinical site and data monitoring and associated monitoring visit reports
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Evaluates clinical data and coordinates data query resolutions
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Performs source data verification
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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
