KEY AREAS OF RESPONSIBILITY

Site Management

Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout

Ensure collection of high quality data, timely adverse event reporting, subject protection and compliance to the protocol

Adherence to ICH-GCP, regulatory requirements, local ethics requirements, Company SOPs, and Clinical Development Guidelines

Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met

Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones

Trains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filing

Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.

Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines

Completes system training (IMPACT, IV/WRS, EDC, CATS, CONCUR etc.) in order to adhere to protocol and SOP timelines to meet required deliverables.

Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team

Identify potential risks and proactively take action to prevent or mitigate

Participates in Sponsor and Regulatory audits in Canada; preparing external trial staff and site records, addressing questions from Auditor, supporting external trial staff during audit, preparing audit responses ensuring compliance to local guidelines, Company SOPs and ICH-GCP.

Other:

Adheres to Company policies, procedures ,vision and fundamentals

Acts as back up to the other monitors during absences, as requested

Performs other tasks as assigned by management

WORKING CONDITIONS

Works from a home office environment at least one day a week

Works at hospitals, medical clinics three to four times a week

May be required to drive, fly or take train to location to perform duties of the job

Up to 70% travel required