Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements
Job Summary
Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements.
Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution, potentially supporting the start-up phase.
Create and maintain documentation regarding site management, monitoring findings, and action plans, collaborating with study team members for project execution support.
Matching Summary
Perform monitoring and site management work to ensure sites conduct studies and report data as required by the protocol, regulations, and sponsor requirements.
Salary
Base: $57,500.00 - $226,800.00; Bonus/Equity: Incentive plans, bonuses may be offered; Benefits: Range of health and welfare and/or other benefits
Skills & Requirements
Must-have
Site monitoring visits
Subject recruitment plan
Protocol and study training
Quality and integrity evaluation
Trial Master File (TMF)
Investigator's Site File (ISF)
Nice-to-have
Effective time management
Problem-solving skills
Client relationship management
Key Requirements
Bachelor's Degree in scientific discipline or health care preferred
At least 2 years of on-site monitoring experience
Good Clinical Practice (GCP) knowledge
ICH guidelines knowledge
Proficiency in Microsoft Word, Excel, and PowerPoint
Work Rights
Must reside in the same country where the job is located