A health care professional with about 6 years of experience in research management, data collection entry and analysis, Clinical Research, Administrative operations as well as good experience in medical records * Proficient with healthcare administration functions, including claims processing, eligibility verification, provider verification and preauthorization and HIPAA regulations * Obtain relevant medical information from patient clinic charts/medical records. Maintain logs/progress reports to track both currently enrolled as well as follow-up participants * Evaluate clinical data documentation, Enter claims data into system * Knowledge of the principles of clinical research, Trial Master File, Protocol specific procedures and Protocol Documents * Support company quality initiatives and ensure facility maintains quality manual * Provide support concerning quality issues (aiding investigations, and customer feedback). Aid in response to Customer Inquiries for Quality Questionnaires * Serves as Lead Auditor in Internal Plant Quality Audits to include performing quality awareness training as needed. * Knowledge on ICH/GCP Guidelines, Regulatory protocol specific requirements and the IRB federal regulations * Expertise in Trial Master File management and maintenance (paper and eTMF) * Efficient with all activities related to clinical phase I/II Oncology clinical trials. * Sound knowledge of ICH/GCP guidelines and FDA regulations * Excellent communication and organizational skills, along with problem solving, conflict management, leadership and team-building skills * Participates in quarterly peer-review, quality control program. Determine data to be collected and develop forms for collecting/summarizing data * Work with the Data Coordinator to enter data onto case report forms and/or into computer database as appropriate. * Work with Microsoft Word 10, Power Point, Excel, Access, Onbase and Epic * Experience in therapeutic areas like Oncology, CNS and Cardiology etc. * Process claim forms, adjudicates for provision of deductibles, co-pays, co-insurance maximums and provider settlements * Follow adjudication policies and procedures to make sure proper payment of claims * Provide timely customer service to members, providers, billing departments and other insurance companies on the subject of claims * Extensive knowledge of human physiology and human anatomy * Assist in verifying subject eligibility according to protocols by reviewing medical records, * laboratory, and radiology results. Access patient toxicity and response to investigational therapy * Organize and maintain all documentation required by sponsor or clinical research organizations * Work with the Data Coordinator to enter data onto case report forms and/or into computer database as appropriate
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