· Sr. CRAs/CRAs may function as leader for clinical site management aspects on one or more clinical trials, and will contribute to the Site Management functional group, including working on continuous process improvement initiatives
· Responsible for ensuring deliverables, where assigned, as lead for clinical research project(s), including leading other team members within the clinical site management group
· Responsible for management of day to day activities of vendor outsourced clinical site activities, including ensuring vendors meet related deliverables
· May manage small clinical study as Clinical Study Team Lead under the supervision of a Manager of Clinical Operations or higher
Project Related Planning, Management and Execution
· Assists with the preparation of and/or review of synopses, protocols and amendments, and responsible for ensuring creation of ICFs
· Responsible for ensuring development of site-level Study Documents (e.g. reference manuals, Laboratory manuals, CRF Completion Guidelines, forms, etc.) and availability of site supplies (e.g. laboratory kits, clinical trial materials, etc.) within designated timelines
· Responsible for ensuring development of, contributing to and/or writing site-level project plans, including the monitoring plan for any assigned projects, drug accountability and reconciliation plans
· Manages drug accountability process, working with Pharmaceutical Science personnel regarding any drug-related issues (e.g., re-test updates and documentation, drug supply updates, etc.)
· Produce and provide clinical research project metrics and functional department metrics as required
· Responsible for ensuring activities being conducted and/or overseen by the Sr. CRA/CRA are within established budget parameters.
· Coordinate with safety management the flow of information to sites of safety updates and follow-up regarding timeliness and confirmation of IRB submissions. As required, may assist with review of serious adverse events (SAEs), follow-up requests, and SAE reconciliation
· Responsible for ensuring clinical research project team is provided site-level information as appropriate for required reports, including but not limited to CSRs, safety reporting, etc.
· Where applicable, Sr. CRA/CRA will participate in review of study results documents and report requirements, including but not limited to review of CSRs, annual safety reports, Case Report Forms, data tables and listings, etc.
· Carries out job responsibilities and assignments safely and maintain a clean and safe work area
· Other duties as assigned (e.g. assist other departments with ad hoc assignments related to cross study data review, etc.)