Clinical Research Monitor (Remote)

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12846BR

Title

Clinical Research Monitor (Remote)

Job Description

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
  
  

Auto Req ID

12846BR

Location:

Aliso Viejo, California, USA

Department Name

1510-Clinical Research SMI

Qualifications

• Strong collaborative and communication skills with demonstrated ability to work with physicians, site coordinators, vendors and others within the company
• Knowledge of clinical procedures
• Excellent written and oral communication skills, including computer literacy to include MS Office Word and Excel
• Extremely detail-oriented
• Good interpersonal skills
• Ability to maintain strict confidentiality
• Bachelor’s Degree or equivalent experience
• Experience in the medical device industry (preferable)
• Experience with Regulatory requirements for medical devices (preferable)
• Five years of general office experience with a minimum of one year of Clinical Research experience
• Experience with MS Word, Excel and Outlook
• Ability to travel locally on occasion
• Availability to work evenings and weekends intermittently as needed
  
  

External-Facing Title

Clinical Research Monitor

Salary Range

$75,000 - $95,000

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.