Senior Clinical Research Associate

Description

• 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.

Qualifications

Highest qualification: University

• 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
• Accountable, dependable and strong commitment