The Director of the Clinical Trials Office (CTO) at Dartmouth-Hitchcock Medical Center is responsible for the daily management and operations of clinical research financial, regulatory and compliance services to all Dartmouth and Dartmouth-Hitchcock facilities. The Director will oversee and assume responsibility for clinical trial billing compliance, 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, and will work in close collaboration with the Directors of Compliance Services, Revenue Management, Office of Sponsored Programs, and the Institutional Review Board. Other areas of responsibility include:

•	Ensure the creation and quality review of Medicare Coverage Analyses for all clinical trials
•	Oversight of the process to register all clinical trials and link all clinical trial participants in the institution’s central clinical trial management system and the electronic medical record and billing systems; and ensure that clinical research income is properly received and accounted for in institutional financial systems.
•	Facilitate timely and appropriate communication with Principal Investigators and Research Nurses/Coordinators on all aspects of clinical research administration
•	Expand the regulatory Monitoring Program and the Research Subject Advocacy Program to ensure compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) regulations and the Informed Consent process.
•	Develop, organize, and/or conduct clinical research administration and regulatory educational programs

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.

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 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.

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