Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines and scheduling site visits for monitoring as required by protocol monitoring visit windows.
Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
Planning day-to-day activities for study monitoring, setting priorities by site. preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
Gauging the quality of clinical deliverables and addressing quality issues with team members.
Managing query resolution with study sites and Premier Research data management operations.
Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
Working with the line manager and CM to ensure that visit metrics are maintained as required.
Participating in Investigators’ Meetings as assigned by Project Managers.
Participating in training offered to increase therapeutic knowledge and keeping current with regulations and TGA guidance.
In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
Bachelor’s degree, or local equivalent, in a clinical, biological, scientific, or health-related field or its international equivalent
4+ years of independent on-site monitoring experience with all types of site visits
Completion of a CRA training program through a CRO
Excellent team player, collaborative and able to build an effective team.
Ability to multitask, prioritize, and work effectively in a fast-paced environment