Perform site monitoring visits including selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and regulatory requirements
Job Summary
Perform site monitoring visits including selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and regulatory requirements.
Administer protocol and related study training to assigned sites and establish regular lines of communication to manage project expectations and issues.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and generating follow-up letters.
Matching Summary
Perform site monitoring visits including selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and regulatory requirements.
Skills & Requirements
Must-have
Site monitoring visits
Protocol and study training
Quality and integrity evaluation
Trial Master File (TMF) maintenance
Investigator's Site File (ISF) maintenance
Good Clinical Practice (GCP)
International Conference on Harmonization (ICH)
Nice-to-have
Adapt and drive subject recruitment
Mentor clinical staff
Collaborate with study team members
Effective time management skills
Problem-solving skills
Key Requirements
4-5 years on-site monitoring experience
1 year as a SR CRA
Bachelor's Degree in scientific discipline or health care preferred
Proficiency in Microsoft Word, Excel and PowerPoint