Job Summary: Position is responsible for executing the business processes associated with the set-up of new clinical trials, grants, foundation projects, and internally funded investigator initiated projects. Responsible for reviewing feasibility of proposed research projects. Responsible for budget development of research projects. Responsible for contract negotiation with sponsors of research projects. Determine the billable and non billable costs of research by completing a coverage analysis on all proposed projects. Responsible for ensuring compliance with federal and state laws, regulations and governmental or sponsor requirements, and the Lehigh Valley Health Network Inc. Compliance Program for the research patient care billing process. Reports to the Director of Research Administration within the Network Office of Research and Innovation.
Minimum Requirements: RN Required Bachelors Degree in a relevant field of study.
Minimum of three (3) years of experience in a healthcare environment. Be familiar with clinical trial and study operations, research financial administration, human subjects protection, research compliance and hospital billing.
Familiarity with clinical research. Knowledge of patient care billing and budgeting. Experience in dealing with physician investigators. Strong communication and interpersonal skills. Computer, word processing, presentation and spreadsheet skills.
Preferred Qualifications: The ideal candidate will: Have over three (3) years of experience in managing clinical trials. Knowledge of FDA Good Clinical Practices, OMB Circular A-110, A-122, and A-133, OHRP and AAHRPP guidance, 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR Part 46, and other applicable research regulation. Demonstrated leadership ability and execution of office or program objectives. Flexible and is comfortable working in an uncertain and fast paced environment. Knowledge of regulatory and contractual requirements for compliant research patient care billing.
Internal Number: 4313
About Lehigh Valley Health Network
At Lehigh Valley Health Network, we continually go the extra mile to fulfill our mission to heal,comfort and care for the people of our community. Each one of our more than 18,000 colleagues contributes to this mission and helps make the Lehigh Valley a healthier – and better – place in which to live.