Responsible for monitoring of the participant study sites, as laid out in ICH/GCP chapter 5.18 ‘Monitoring’.• Knowledge of applicable SOPs, guidelines and study procedures;• Assist with protocol and CRF review• Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials;• Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.• Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.• Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.• Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines• Coordinate timely shipment of clinical supplies and study drug to sites.• Ensure proper storage, dispensation and accountability of clinical supplies and study drug.• Follow up of drug safety issues and safety reports in timely manner, if applicable• Communicate site study issues, concerns, and progress Project Manager, Clinical Team Lead, Regional Monitoring Manager and Clinical Operations Manager accordingly• Assist with data query form (incl. query process)• Conduct on the job training and formal training to other CRAs and Clinical Trials Assistants• Collaborate with Regional Monitoring Manager or Clinical Operations Manager /study teams to resolve site issues• Review study visit reports, follow-up letters and site communication generated by other CRAs for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from Clinical Team Lead, Regional Monitoring Manager or Clinical Operations Manager as needed• Participate in routine study progress meetings, face to face or via teleconference.

Clinical Drug Researce