Erin Jacques Email & Phone Number

Bridgewater, New Jersey, United States

North Carolina, United States

Manage Avoca Quality Consortium Projects and workstream activities.

North Carolina, United States

Remote

Senior team member with a lead role in the evaluation and qualification of new and existing clinical service providers. Collaborate across the organization regarding category and study selection, qualification, documentation and oversight of clinical service providers. Responsible for ensuring contractual fulfillment and handling escalation of issues involving vendors. • Lead the day-to-day activities associated with vendor selection, qualification, and oversight• Lead monthly collaborative meetings with several other business units within the organization• Facilitate Lesson’s Learned and bi-monthly/quarterly vendor meetings• Manage resolution of performance issues, including CAPA initiation and closure • Drive efficiencies around vendor selection, qualification (remotely and onsite), and oversight • Regularly collaborate with functional department leads • Support Quality Assurance with pre-audit inspection activities• Develop, monitor and collect vendor metrics, industry trending information, KPI’s, draft Governance Oversight Charters and perform risk based annual reviews• Support SOP updates/revisions, maintain vendor database, FirstDoc (TMF) and SharePoint

Manage the day-to-day contract development process of large complex contracts.Manage project requirements, identify discrepancies and interact with customers to resolve issues.Assist in the negotiation of legal contracting text using INC Research’s Contracting language and templates. Resolve negotiation disputes and/or escalate irreconcilable issues to management’s legal team. Participate in complex negotiations of contract, scope of work and budgets as required.Perform quality control edits on all documents, Represent Contracts team at customer meetings and on task forces as required, Work closely with team members to ensure collaboration and efficient working practices.

Remote

Facilitate review of Scope of Work document and associated costing – Work with internal and external customers to amend SOWs and POs Verify budget pricing and invoice pricing Oversee financial execution of PORequest funds from finance Raise and facilitate electronic commitment request POOversee PO execution by monitoring the approval chain of command Monitor SoW throughout study and amend as appropriate, liaising with supplier and internal customers Facilitate and drive internal stakeholder meetings to consider proper trending of the budget vs. the stage of studyReview and evaluate trending of the budgetFacilitate the closure of the services and associated PO Review, investigate, and resolve outstanding supplier invoices Support the creation of Sponsor reports as required Track and archive relevant correspondence and associated documentation

Raleigh, Nc

Completed project activities associated with monitoring functions of Phase I-IV clinical research studies Performed remote management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.Site Management - supported patient enrollment and training. Implemented plans for sites who are not meeting metrics.Monitoring - monitored Phase I-IV clinical trialsMaintained study applications including the study portal and trial management systemReviewed essential documents for content through all phases of the studyMaintained study central files and site regulatory filesWrote and resolved queries.Reviewed and prepared IRB submission materialsProcessed and reported SAEsWrote SAE narrativesAttended Investigator Meetings

Statistics

B.A., Organizational Dev./ Business