International conference on harmonization guidelines
4 years of on-site monitoring experience
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out in accordance with Good Clinical Practice
Job Summary
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out in accordance with Good Clinical Practice.
Candidates must evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
The position requires managing study progress by tracking regulatory submissions, recruitment, enrollment, and data query resolution.
Matching Summary
The role involves performing site monitoring visits including selection, initiation, monitoring, and close-out in accordance with Good Clinical Practice.
Skills & Requirements
Must-have
Good Clinical Practice (GCP) knowledge
International Conference on Harmonization guidelines
4 years of on-site monitoring experience
Microsoft Word Excel PowerPoint proficiency
Protocol and regulatory adherence skills
Nice-to-have
Oncology studies experience preferred
Strong problem-solving and organizational skills
Effective time and financial management skills
Ability to establish client relationships
Experience with site financial management
Key Requirements
Bachelor's Degree in scientific discipline or health care
At least 4 years of on-site monitoring experience
Knowledge of GCP and ICH guidelines
Proficiency in Microsoft Office suite
Equivalent combination of education and experience accepted