Provides oversight for the fiscal management and strategy of clinical research operations at Dartmouth-Hitchcock, encompassing research compliance, clinical trial contracting, and clinical trial coordination.
Provides oversight and management of the Clinical Trials Office, Clinical Research Unit(s), and Research Operations Managers in the Divisional research teams.
Provides oversight and management of Pre-Award for sponsored projects
Provides administrative oversight and management for Centralized Research Labs (i.e. Research Lab, and Research Imaging)
Leads the implementation of Research IT administrative systems
Works collaboratively with VP of ORO, Chief Research Officer and Investigators to initiative and implement research programs and centers.
Works collaboratively with Corporate Finance Director, Director of Research Finance and the Senior Manager for Business Operations to direct the management and administration of the financial operations of CTO, CRU, and divisional research study accounts.
Collaborates with the Director of Research Finance on award accounting and contracting issues.
Leads efforts to ensure effective team dynamics and teamwork to maximize productivity, ensure researcher and staff satisfaction, and minimize staff turnover while maintaining high quality standards.
Collaborates with research staff and leadership as well as other functional groups, across multiple projects, to ensure timelines and financial goals are being met by utilizing and analyzing information in the project cost plans and other management tools.
Initiates, leads, develops and implements key organizational and Clinical Operations group initiatives within/across assigned work units
Training and development of work unit staff
Development and implementation of process improvements and guidelines (including SOPs)
Directs and oversees research functions for Dartmouth-Hitchcock, striving to promote conduct of safe, compliant, and high-quality research.
Monitors and analyzes metrics for workload volume, productivity, utilization and other metrics to ensure projects are conducted with optimal efficiency.
Initiates, leads, develops and implements key organizational and functional group initiatives within/across the therapeutic areas/subgroups including training, staff development, process improvements, quality management and other initiatives.
Participates as member of core team with Faculty Leaders, Directors, Managers, and other functional group key representatives.
Leads quality improvement and advancement in research operations in presentations and other interactions with partners. In collaboration with leadership; monitors and manages budget and quality adherence in research operations.
Assesses overall project/subgroup metrics and study timelines across site management and monitoring; identifies trends; makes recommendations to operations management for process improvements/implementation of best practices across Research Operations.
Provides input and approval in the development/revisions of pricing models for activities and services for Research Operations.
Interviews job candidates and makes hiring decisions for positions across Research Operations.
Actively participates in appropriate Clinical Operations leadership meetings, department meetings and organizational meetings.
Serves as leadership resource for Research Operations staff and monitoring and cross functional personnel regarding the operational aspects of clinical research.
Performs other duties as required or assigned.
Master’s degree with 5 years of clinical research, or the equivalent experience required.
Prior experience supervising staff required.
A strong clinical research regulatory background required.
Excellent written and oral communications skills, including ability to speak in front of groups required.
Knowledge of Federal healthcare and commercial insurer billing and coding manuals and regulations is strongly desired.
Ability to perform regulatory research, interact productively in a wide variety of situations, and command the respect and confidence of broad members, faculty, and research staff required.
Knowledge of computer databases and general computing software is essential, and experience with clinical trial management system is desired.
Required Licensure/Certification Skills:
Certification through the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required, and/or obtained during the first two (2) years of employment.