Perform monitoring and site management work to ensure sites are conducting studies and reporting data as required by the study protocol, regulations, and sponsor requirements
Job Summary
Perform monitoring and site management work to ensure sites are conducting studies and reporting data as required by the study protocol, regulations, and sponsor requirements.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans.
Matching Summary
Perform monitoring and site management work to ensure sites are conducting studies and reporting data as required by the study protocol, regulations, and sponsor requirements.
Skills & Requirements
Must-have
site monitoring visits
protocol and regulatory adherence
subject recruitment planning
quality and integrity evaluation
trial master file maintenance
Nice-to-have
effective time management
establish working relationships
problem-solving skills
financial management skills
Key Requirements
Bachelor's Degree in scientific discipline or health care preferred
Prior on-site monitoring experience
Basic knowledge of GCP and ICH guidelines
Proficiency in Microsoft Word, Excel, and PowerPoint
Written and verbal communication skills in English