Bachelor’s Degree in an applicable related field with three (3) to five (5) years relevant experience. (An applicable related field may be the life sciences, business administration, accounting, research administration/study coordination, nursing); in lieu of Bachelor’s degree, an RN with associates degree and (5) to (7) years Research experience.
·Good analytical skills and strong attention to detail.
·Professional, team oriented attitude.
·Excellent oral and written communications skills.
·Effective organization and time management skills.
Advanced experience using spreadsheet, database and word processor applications.
·Knowledge of key regulations regarding research transactions: CMS / FDA / OHRP / ORI / DHHS.
·Understanding of Medicare billing rules and functional knowledge of essential National Coverage Decisions and Medicare Clinical Trial Policy. Experience working with patient bills and/or coding is preferred.
·Knowledge of drug/device development process and the pharmaceutical and/or medical device manufacturing industry is preferred.
·Knowledge of Process Improvement tools and concepts.
Primary Job Functions
This position will work closely with essential research constituencies (e.g. PIs, research coordinators, financial and billing services, compliance and quality services, and corporate-level legal counsel) to ensure the efficient and compliant initiation and ongoing administrative management of clinical research.
Serves as a central point of contact for and liaison to the research community (Principal Investigators (PIs), Institutional Review Board, research coordinators, administrators, and physician groups conducting research) to provide guidance related to the initiation and ongoing conduct of clinical research.
Participates with PIs and research staff in study feasibility analysis and budget preparation.
Creates, in conjunction with PI's and research staff, a Medicare Coverage Analysis at the inception of each study. Communicates responsible payer information to appropriate patient billing personnel in the PHS Business Office.
Coordinates drafting and periodic updating of clinical research-related policies and standard operating procedures. Stays abreast of regulatory developments to ensure that PHS policies are in alignment with current regulations.
Establishes and maintains effective systems for identifying newly entered studies; tracking the status of existing studies (including milestones and sponsor billing); tracking new agreements throughout review process, and turnaround time.
Presbyterian Healthcare Services - 9 months ago