We have a new position available at the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire. Please see below for full details. --Tina Tina G. Noonan Vice President for Clinical Research Operations Dartmouth-Hitchcock Medical Center One Medical Center Drive Lebanon, NH 03756 xxxxxx@hitchcock.org Director of Clinical Research Administration - Clinical Trials Office The Director will oversee and assume responsibility for clinical trial billing compliance to trial sponsors, appropriate identification of charges billable to third party payors, contract negotiation/budget development, feasibility analysis, regulatory support and ongoing post award management for clinical trials. This position reports directly to the Vice President of Clinical Research Operations within the Clinical Trials Office and will work in close collaboration with the Directors of Compliance Services and Revenue Management Division. The Director of Clinical Research Administration is also responsible for the daily management and operations of clinical research financial, regulatory and compliance services to all Dartmouth and Dartmouth-Hitchcock facilities. Other areas of responsibility include: • Ensuring the creation of Medicare Coverage Analyses for all clinical trials • Providing for a Quality Assurance process to continually improve process accuracy and timeliness • Oversight of the process to ensure all clinical trials are registered and all clinical trial participants are appropriately linked to downstream clinical information and billing systems; and that clinical research income is properly received and accounted for in institutional financial systems. • Participating in annual research fee schedule updates and facilitating communication with Principal Investigators and Research Coordinators on changes. • Establishing a regulatory Monitoring Program and Research Subject Advocacy Program to review clinical trials for compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) regulations and the Informed Consent process. The Director will also ensure that the office provides knowledgeable, friendly, professional and timely support to faculty and staff. This individual is also responsible for safeguarding Dartmouth’s interests by assuring compliance with various Federal and State regulations and laws, as well as Institutional policies associated with management of clinical research. This position will be responsible for developing, with the Vice President for Clinical Research Operations, CTO policies and procedures relating to corporate sponsored clinical research. The ability to manage a diverse staff of clinical research experts and have a deep understanding of the clinical trial process and the impact of CTO operations on that process is required. You will be responsible for developing, organizing, participating in, and/or conducting portions of orientations, workshops, presentations, etc. regarding sponsored clinical research, proposal writing and submissions. Requirements include a Master’s degree with a minimum of 5 years of clinical research, or the equivalent and prior experience supervising staff. A strong clinical research regulatory background as well as excellent written and oral communication skills, including the ability to speak in front of groups is essential. Knowledge of clinical research regulations and Federal and State law governing clinical research and tax-exempt organizations is required. Knowledge of Federal healthcare and commercial insurer billing and coding manuals and regulations is strongly desired. Knowledge of computer databases and general computing software is essential, and experience with clinical trial management systems is desired. Dartmouth-Hitchcock Medical Center includes a modern 400-bed tertiary care hospital with level one trauma center, research and clinical facilities for Dartmouth Medical School, Norris Cotton Cancer Center, The Children’s Hospital at Dartmouth and the Dartmouth-Hitchcock Clinic. U.S. News & World Report has consistently rated Dartmouth-Hitchcock Medical Center one of America’s Best Hospitals. The Medical Center is located in Lebanon, New Hampshire on the Vermont/New Hampshire border. The area, home to Dartmouth College, is a vibrant academic and professional community offering excellent schools and a lively arts scene in a beautiful rural area. Applicants are encouraged to apply online at: www.dhmc.org Dartmouth-Hitchcock Medical Center One Medical Center Drive Lebanon, NH 03756 We are an equal opportunity/affirmative action employer. ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
