Weir Clinical Solutions, Inc Work Values

Daily Duties at Weir Clinical Solutions, Inc:

Medical Writier Responsibilities : • Develop and Maintain SOPs for Specialized Clinical Research Cancer Center • Develop and Conduct Training modules for research team for Specialized Clinical Research Cancer Center. • Develop and implement compliance action responses for current research center trial audits • Prepare clinical research team for FDA audit Sr. CRA Responsibilities: • Conduct monitoring visits in compliance with Good Clinical Practices and FDA regulations • Remote Resolve Data Clarification Queries • Collect and maintain Regulatory documents • Prepare and submit timely project deliverables such as detail trip reports and telephone contact reports • Responsible providing updates to sponsor re: serious adverse events, IRB, communications files, and site SOP; site staff changes • Responsible for reviewing and updating electronic data bases. • Responsible for data query completion and resolution, collection and processing of immediately reportable adverse events and serious adverse events • Systems : EDC: PPD Oracle RDC , Electronic Trial Master File ( Pfizer, Bristol-Myers Squibb), Web portal IVRS system maintenance., E-Pip, CTMS ( Portola) Oracle Clinical • Developed record keeping tracking system for maintaining project, and site files. • Responsible for data query completion and resolution, collection and processing of immediately reportable adverse events and serious adverse events • Responsible for collection of financial disclosure information from investigative sites, tracking of clinical study documents • Prepare and submit timely project deliverables such as detail trip reports, project status reports, develop and maintain site information tracking files. • 20 sites total; utilize in house personnel as additional monitoring support staff. • Conduct interim -Close out monitoring visits in compliance with Good Clinical Practices and FDA regulations; implementing corrective actions as necessary in compliance with GCP and FDA regulations. • Maintained Trial Master Files • Performs contracted audits according to client expectations SOPs. - Plans and ensures audits are scheduled - Conducts audits to identify non‐conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness - Reports non‐conformities according to client or PRA SOPs and report templates - Tracks, collects and reports responses and corrective actions per contract with client Project Management Responsibilities: • Developed site study specific SOP’s • Develop and implement study management the following documents - Protocol - Pharmacy manual - Operations Manual - Clinical Management Plan - Study source documents, and Information Slides ( Protocol design, Disease Process, RECIST criteria training, NIC AE training, SIV presentations) - Case Report forms - Study Monitoring Reports: PSSV, SIV, IMV, COV - Study Management tracking tools: Enrollment, CRF recovery, AE & SAE tracking, Regulatory tracking tools - Upper Management Study report - Study Metrics  Manage clinical trial monitors - Report review, tracking and reconciliation - Study visit scheduling - Site support  Manage clinical daily operations - Monitoring support - Study support venders - SAE reporting - OBA / RAC submissions/ site correspondence, compliance and reconciliation - Monthly newsletter Additional Duties & Responsibilities: Medical Writer - DDW Poster Presentation - ASCO Poster Presentation - Protocol Design - Interim Analysis Review Clinical Education Administrator - RECIST Criteria - WHO Criteria - CTACE - Oncology : Develop and deliver clinical team learning modules & Staging: Guidelines

What they like about Weir Clinical Solutions, Inc:

Working for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.

Tags

South East, Sr. CRA, Rare Disease CRA, Oncology CRA, Cardiology CRA, Vaccine CRA, Project Manager, Lead CRA

Skills

Project Management, Sr. Clinical Research Associate, Lead CRA, Registered Nurse

These are some of the questions we asked our climbers about their experiences with Weir Clinical Solutions, Inc: