Clinical Data Assistant Senior-Oncology

Sr Research Data AssistantEnsures submission and maintenance of accurate, timely, complete and reliable data and reports by implementing data management and quality assurance procedures. The primary purpose of the Sr Research Data Assistant is to coordinate data collection and management in accordance with departmental research objectives. The coordinator serves as a liaison between the clinical research team, internal departments, external sponsors, and all regulatory entities. The data assistant will also serve as a team lead to new data assistants. Develops and maintains system for controlling documentation flow for protocols, including by not limited to, medical records, laboratory and pathology information, regulatory documents and case report forms. Enters required data into data controls systems. Assists with protocol updates and chart audits. Assist the investigator in data file preparation and participates in data review meetings as required by the department. Collaborates with multidisciplinary team individually and in group meetings. Assists in preparations activities for Audits or Inspections.Strategic Planning: Participates in team and other departmental meetings to share experiences, learn about what other teams are doing and help solve problems.Administration: Ensures completion of case report form entry, query resolution and data monitoring reporting activities are completed on time and with quality. Assigned to higher complexity early phase trials Monitors toxicity and response to study agent data. Tracks protocol related labs, response and research related tests for abstracts and/or manuscript submissions Manages flow of auditors and/or monitors for assigned protocols. Includes oversight of the monitor visit and assurance of the completion of auditor/monitor checklists Assists investigators in overall conduct of clinical trials assigned. Participates in development on eCRFs for internal studies and attends all site implementation meetings Responds to sponsor/CRO data concerns and escalates issues to management as appropriate. Participate in conference calls and/or meetings with vendors. Increase knowledge of all disease specific oncology studies to ensure efficient data abstraction and resolution of queries. Gives input on CTO policies and procedures with regards to data entry/monitoring.Development: Determines data needed to be collected and the appropriate data resources for specific study/project needs. Ensures data in CTMS system up to date for assigned teams Runs reports and quality checks in CTMS Abstract all required patient data from medical record sources for entry into case report forms (paper and/or electronic). Seek out data by contacting other hospitals and physician offices to obtain medical records as needed. Main contact for monitors/CRO's for data query resolution. Collaborate with DB vendors on consistent basis to address clinical team requests, respond to sponsor queries, and resolve technical issues. Ensure clinical data within EDC is in quality to lock/unlock as appropriate for statistical review, interim review, and or final database locks. Perform close-out duties specified by sponsors for closing studies in EDC's. Facilitate EMR access for monitors. Assists with any sponsor and/or internal audit requests and responses Performance Trains new data assistants Leads team in data finding responses during audits and inspections Is available to lead data review with auditors and inspectors Reviews data input for accuracy, addressing on skip patterns, coding, and other information. Performs cleaning/formatting tasks of datasets. Follow timelines stated in SOP and individual sponsor contracts, for data entry and query resolution. Manages data reconciliation and is responsible for oversight of data locks on assigned protocols. Resolve issues noted in follow up letter within 3 weeks. Assesses protocol compliance and communicates directly with the study coordinator and PI when compliance issues are identified.Miscellaneous: Performs other duties as assigned.Minimum Qualifications: (Education, experience, and any other certifications or clearances) A high school diploma or equivalent is required. 1-2 years experience in clinical research-oncology preferred Medical terminology proficiency and/or experience in a clinical setting preferred eIRB Kronos Mac OS X Operating System Microsoft Exchange Minimum Competencies: (Skills, knowledge, and abilities.) Ability to understand complex pathology data and cancer treatment regimens and their toxicity. Ability to establish and maintain effective working relationships with patients, physicians, nurses, technicians and co-workers. Excellent verbal and written communication Medical terminology. Preferred Qualifications: (Education and experience) Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience. Experience in data management in a health field, exposure to cancer clinical trials. Computer literate in basic software, internet use, and cancer-related databases. Preferred Competencies: (Skills, knowledge, and abilities) -2 years' experience in cancer Experience with databases Rave and Redcap Experience working on Phase 1-IV clinical trials