This position will support and observe clinical site monitoring services inhouse and provide monitoring and site management activities for full-service studies assessing for protocol, SOP and regulatory compliance. Responsibilities include site management activities to help drive investigative sites and patient recruitment, compliance and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.
Site Management
Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per SOPs, Monitoring Plan and study guidance, including creating contact reports for each telephone session (outbound or inbound) with sites.
Act as the first point of contact for site when the CRA is absent.
Manage and file site specific documents in (e) TMF.
Assist Clinical Research Associates (CRA) with preparation for site visits (i.e. running reports, QC of files and checking for missing documents in the TMF, resolving action items and queries from previous visits).
Perform Case Report Form review, query generation and resolution against established data review guidelines and the monitoring plan.
Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
Assist with the coordination of study visits, shipment study supplies and system access or updates.
Manage sites to ensure compliance with protocol requirements, study visits, and data entry timelines.
Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
Liaise with the Project Coordinator, Project Manager and or Clinical Operation Lead (COL) in the production of Status Reports.
Assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As applicable in region.
Occasionally, if needed, perform remote visits (i.e. qualification, site initiation, interim and close out visits) as required by the monitoring plan, but does not perform remote monitoring that requires SDV.
General Monitoring Responsibilities: perform onsite visits as co-monitor if needed.
Supports preparation for audit and required follow-up actions.
Site Setup and Startup Support
Potentially support with identification and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal products, protocols, SOPs, CRFs, project documents, forms, and support tools.
Support patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
Training and Development
Support and observe primary assigned CRAs at both onsite and remote visits.
Support COLs with remote site management activities.
Participate in all study related activities, including but not limited to training, team meetings and provide any necessary updates to the study team.
Qualifications
Undergraduate university degree (Bachelor or Honors Bachelor), & 1-3 years' related experience with initial and On-going training.
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