Description
Senior Clinical Research Associate:- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Schedules site visits for monitoring as required by protocol monitoring visit windows
- Maintains submission of expenses according to travel and expense requirements within company guidelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH-GCP/ISO141155, protocol and client requirements
RESPONSIBILITIES
Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Plans day to day activities for monitoring of a clinical study and sets priorities per site
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
- Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
- Monitors with knowledge of quality/scope and budget parameters
- Escalates issues and feedback for the team
- Works with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase
- Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
- Provides accurate and timely submission of trip reports
- Manages query resolution process with sites and Premier Research Data Management
- Assists project team with assessing project feasibility and recruitment, as applicable
- Maintains project tracking system of subjects and site information as applicable
- Participates in Investigators' Meeting as designated by Project Manager
- Manages investigative sites via telephone calls between visits
- Ensures adherence to study timeline and budget
- Attends meetings as required
- Performs additional duties and assignments, as requested
This person should have:
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site monitoring activities will be carried out