Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements
Job Summary
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, 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 by submitting regular visit reports, generating follow-up letters and other required study documentation.
Matching Summary
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Skills & Requirements
Must-have
site monitoring visits
protocol adherence
regulatory requirements
GCP and ICH guidelines
subject recruitment plan
CRF completion and submission
Nice-to-have
effective time management
problem-solving skills
collaboration with study team
Key Requirements
Bachelor's Degree in scientific discipline or health care preferred
Basic knowledge of applicable clinical research regulatory requirements
Proficiency in Microsoft Word, Excel and PowerPoint