Clinical Monitoring Associate I

Role Focus:

• Perform in-house and remote monitoring activities for clinical trials, ensuring compliance with regulatory requirements, SOPs, and study protocols.
• Support on-site monitoring, co-monitoring, and study close-out activities under the supervision of Clinical Research Associates.
• Assist with study start-up activities, including site selection, feasibility support, and pre-study visits.

Responsibilities:

• Collect, review, track, and file essential regulatory documents and contribute to TMF/eTMF reconciliation.
• Conduct remote monitoring of eCRF-based studies, including query generation, follow-up, and resolution tracking.
• Maintain study tracking tools covering visit reports, deviations, SAEs, and regulatory safety documentation.

Qualifications:

• 1+ year of experience in clinical research, healthcare, or a related scientific field.
• Bachelor's degree in Nursing, Pharmacy, Health Sciences, or Biology.
• Familiarity with clinical trial processes, medical terminology, and ICH-GCP preferred.