Clinical Research Monitor

Company Name:
Jacobs Management Group, Inc.
Participates in the, administration, and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives.
Manage multiple investigational sites, for possibly same or multiple trials
Coordinate effective communication between investigational sites, study and data management teams, to include the study sponsor
Ensure investigational sites maintain requisite regulatory and study specific documentation and are aware of their obligations
Conduct pre-study, site initiation, interim monitoring, and study closeout visits and complete associated reporting requirements in accordance with GCP, company SOPs, and/or any other guidelines (sponsor, founder)
Perform source document verification, retrieve and review CRFs (and/or EDC) and verify completeness and accuracy at sites on a regular basis and/or according to the monitoring plan
Perform queries resolution in a timely manner
Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports
Ensure Serious Adverse Event (SAE) reporting according to project specifications
Review protocols for completeness and feasibility
Work under the supervision of the clinical trial manager to drive patient recruitment strategies and enrollment plans
Assist in writing clinical study reports by reviewing tables and listings generated from study data
Additional duties and responsibilities as assigned
Qualifications
Excellent written and verbal communication skills
Excellent organizational skills
Detail oriented
Ability to manage time and work independently
Ability to interact effectively with many different team members
Excellent MS Office skills to include Word, Excel, and PowerPoint
A minimum of 2-3 years' experience in a medical device company or CRO setting functioning as a Clinical Trial Monitor, research coordinator or equivalent
Knowledge of FDA regulatory requirements, and GCP is required
Hands-on experience with clinical studies start-up, interim, and closeout activities

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