Charra M. Email & Phone Number

United States

• Reviews and submits eligibility documentation into data capture systems for complex studies (phase I, molecular based studies, etc.) Identifies and resolves any documentation discrepancies. Collaborates with regulatory to ensure eligibility criteria are clearly defined and tools to support eligibility processes are in place.• Accountable and responsible for timely submission of all data in carious EDC systems. Monitors documentation for quality and accuracy. Initiates and develops processes to increase efficiency and accuracy of data entry. Manages day to day operational needs as it relates to real time data capture and provides coverage as needed.• Manages sponsor queries to ensure timely response and appropriate communication with PI and study sponsor. Oversees prioritization of studies of high importance (e.g. high accrual, Phase I, meeting data lock, etc.) and assigns work to data team.• External Sponsor Monitor and Visit Management• Quality Assurance/Internal Monitoring• Queries research ream to clarify, reconcile and complete data issues. Develops assessment tools to assist clinical staff during patient visits. Assists data team to communicate effectively with the research team. Collaborates with QA trainer to identify areas for education and quality improvement.• Accountable to resolve all data and EMR discrepancies. Mentors data team in effective discrepancy resolution. Collaborates with QA trainer to identify areas for education and quality improvement• Manages data entry, data lock, monitoring and audit deadlines for complex clinical trial portfolio. • Coordinates and participates in assigned clinical trial audits. Assists data team to prepare for and participate in internal and external audits. Works with Assistant Director of Compliance and QA Manager to understand audit trends, respond to audit findings and develop corrective action plans.

Greater Nashville Area, Tn

• Performing and overseeing all clinical data management activities for multiple studies and phases, from study start up through database lock• Run ancillary programs used to support the review of clinical trial data• Apply quality control procedure and checks to ensure data quality standards are achieved• Assist in the development and testing of data management system edit/data validation checks (diagnostic) and special listings/procedures used as tools for the data review and discrepancy management activities• Perform aggregate review of clinical data by patient, site and project to identify data trends and data inconsistencies that require further investigation• Perform other duties as assigned by management

Nashville, Tennessee

• Generated, resolved and tracked queries to address problematic data identified during data review and apply proper modification/correction to the database• Ran ancillary programs used to support the review of clinical trial data• Applied quality control procedure and checks to ensure data quality standards are achieved• Assisted with reconciliation of Central laboratory and / or third party vendor data• Assisted in development and testing of data management system edit / data validation checks and special listings / procedures used as tolls for the data review and discrepancy management activities• Supported the training of project staff on project-specific, global, standardized data management processes• Performed other duties as assigned by management

Nashville, Tennessee

Greater Nashville Area

•Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan•Assist in preparation of project specific plans for the GSS component of assigned studies•Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable•Assist in review of core Country patient informed consents for compliance to country requirements and protocol as applicable•Assist in review of investigative site specific patient informed consents for required elements •Maintain and update document tracking information in the Trial Tracker TM Site Information Module and other tracking logs•Assess impact of site personnel changes on regulatory documents and process/review new documents according to GCP/ICH guidelines •Assess impact of study amendments on Informed Consent and other study documents and revise and review accordingly•Liaise with applicable IRB/IEC regarding investigator submission/approval issues as appropriate•Setup and maintain investigative site files•Understand and follow project specific and GSS policies and procedures•Perform other duties as assigned by management•Assist with the preparation and dissemination of feasibility documents according to the processes in place•Assume responsibility for contacting and following with investigator sites regarding completion of confidentiality agreements and other information that may be required.

Greater Nashville Area, Tn

•Ensures that documentation consistently meets regulatory requirements•Provide required documentation to Regulatory Affairs for FDA submission filing. •Provide documentation for regulatory inspections as requested.•Maintain and update document tracking information•Working knowledge of FDA requirements for GMP compliance.•Review of investigative site specific patient informed consents for required elements •Excellent communication, detail oriented, verbal, and written skills.•High interaction across functional areas either by email, phone or face-to-face.•Work well with personnel of all levels, skill sets, and authority throughout the company while maintaining a high degree of confidentiality and professionalism.

Greater Nashville Area

•Knowledge and overall understanding of biopharmaceutical manufacturing and manufacturing support processes. •Coordinate, prioritize, expedite, and advise on scanning of Records in QA storage facilities/areas.•Support and guidance to departments requiring Records Storage and/or QA Controlled Documentation support •Advanced proficiency in the use of Microsoft Word, including editing and applying templates and creating and editing complex documents. •Monitor QA Documentation including individual department’s inventory control of contents and organization of documents within. •Develop and apply technical writing skills to implement a streamlined efficient process for batch production tickets. •Approve administrative changes to Controlled Documents for QA.•Accountable for initiation of corrective actions. •Responsible for the implementation of revisions to Controlled Documents owned by QA Documentation.•Flexibility to handle moderate degrees of stress, changes in priorities and frequent interruptions.

Chattanooga, Tennessee Area

•Provide and Instruct supplemental instruction and academic tutoring for all students at the university.•Assist and coach students in registering for courses, understanding university policies, and connecting to campus resources. •Answer phones, File and organize information, Take messages, Running errands, data entry, word processing •Operate office equipment I.E. Fax machines and specific programs Microsoft Word and Excel