Eric Henricks Email & Phone Number

United States

United States

Ann Arbor, Michigan

Launch and execution of a Phase 1 trial that successfully completed all objectives ahead of schedule and under budget, a first for any project within the company. Development of a comprehensive sponsor oversight and co-monitoring plan applicable to global projects across the company portfolio, streamlining clinical trial management and issue mitigation.• Direct initiation and oversight of trial execution in the global clinical space, transitioning projects from company goals to site conduct, including a first-in-human Phase 1 and a Phase 2b trial• Conduct vendor evaluation and selection processes and provide direct oversight and management of vendor performance, including budget and timeline adherence and corrective action plan development when necessary• Negotiate budget and contract terms with vendors to ensure alignment with corporate expectations and requirements• Develop detailed budgets and timelines and ensure adherence by internal and external parties, including invoice reconciliation and approval• Manage multiple internal and external teams and provide direct input to facilitate the successful development of essential study documents and processes, including protocol and pharmacy manual creation, project management plan, and data management plans • Oversee global clinical monitoring activities, complete site visit report review and approval, monitoring plan development oversight and approval, and conduct of co-monitoring visits, both routine and for-cause• Conduct detailed review and approval of study progress and reporting methods, which includes full data review prior to database lock and clinical study report draft review

Ann Arbor, Michigan

Development and facilitation of a successful training program for medical monitors and sites, in the accurate completion of serious adverse event narratives. Creation of a new method of timeline adherence in preparation for data safety monitoring committee meetings, leading to accurate report and table completion ahead of deadlines.• Oversee project management and clinical monitoring for multi-center clinical trials and observational studies in a full-service, university-based CRO• Actively participate in the design, development and execution of clinical trials and observational studies• Manage cross-functional teams in designing protocol-specific case report forms, and facilitating accurate data capture and reporting• Create a study manual of operations and standard data collection procedures for all participating clinical sites• Conduct ongoing site monitoring and initiation visits, and prepare detailed monitoring visit reports• Successful creation and submission of regulatory documents, including IRB submissions, protocol and consent form development, IND submissions, annual reports to the FDA, and Data Safety Monitoring Board reports• Develop and conduct successful investigator and coordinator meetings and teleconferences

Successful establishment of a joint research enterprise with the Ann Arbor Veteran’s Affairs Medical Center, and development of a streamlined budget forecasting and management tool.• Responsible for the successful operation, implementation and completion of numerous clinical trials among multiple Principal Investigators• Manage several clinical research coordinators at two different sites, including hiring and performance reviews, and management of faculty and staff effort• Negotiate budget and contract terms with study sponsors to meet the needs of the University and the sponsor, and ensure strict adherence to final budgets.• Maintain financial and contractual integrity of all studies in the pre and post-award environment• Utilize LEAN principles of fiscal and staff management to promote efficiency• Audit studies to ensure all work flow, data and regulatory requirements are met• Prepare and submit grant proposals to various funding entities, assist with protocol development, and manage post-award monies• Coordinate with other departments and divisions within the UM to facilitate smooth performance of research projects

Successful recruitment, retention, and data submission for several NIH, industry-sponsored and investigator-initiated trials at the University of Michigan (UM) Hospital and Ann Arbor Veterans Affair’s (AAVA) Hospital. Appointed as a department representative to the Service Excellence Committee and Study Coordinator Education Series committee• Manage multiple types of trials, including device trials, drug (contrast) trials, imaging trials and registries.• Serve as a liaison between the study sponsors and the Department of Radiology faculty and staff• Create source and case report form documents for investigator-initiated trials• Develop Standard Operating Procedures (SOP’s) for all studies

Ypsilanti, Michigan

• Responsible for facilitating the successful recruitment, retention, and data management and submission for several large industry and NIH-sponsored drug and device studies. • Screen for appropriate participants from the inpatient, urgent care and ER populations within the hospital.• Coordinate all necessary procedures and manage laboratory specimens, as specified in the study-specific protocols. • Facilitate all follow-up visits and related procedures, obtain vital signs and assess participants for Adverse Events. • Research drug and device management and reconciliation. • Submit regulatory documents and maintain protocol compliance as assessed through monitoring visits, while adhering to Good Clinical Practice guidelines. • Serve as the department Customer Service Ambassador.