The Academic Office of Clinical Trials ('AOCT') provides leadership and staff resources for clinical trials operations. The Director serves in a leadership role and provides strategic oversight of clinical research operations conducted across The Methodist Hospital system. In this capacity, the Director supervises and mentors functional managers and clinical research support personnel in order to ensure effective planning, oversight, and coordination of clinical research projects. The Director also monitors progress and performance of all projects to include quality of services, timelines of deliverables, compliance with regulatory requirements, and adherence to financial targets.
PATIENT AGE GROUP SERVED
Not applicable to this position.
DUTIES AND RESPONSIBILITIES
' Provides strategic oversight of the Academic Office of Clinical trials, including: oversight of the research coordinator and regulatory core, contracts and budgeting, and specialized support for IND/IDE filings
' Provides strategic oversight and develops a program of site based research at the Methodist community hospitals
' Establishes and implements short- and long-range organizational goals, objectives, policies, and operating procedures; monitors and evaluates operational effectiveness; effects changes required for improvement.
' Works with functional managers to identify key operational needs and opportunities for improvement in the conduct of clinical research protocols. Assists with the development of operational tools, resources and capabilities to foster consistency, efficiency, and relationships between internal groups.
' Ensures that all clinical operations activities are carried out in accordance with established research protocols, and with acceptable clinical procedures and safety standards.
' Identifies operational problems, issues, obstacles, and barriers across all projects based on input from investigators, research team members, and sponsors; communicate patterns and trends to TMHRI Administrative Leadership as appropriate; and participates in and supports efforts to develop and implement process/system improvements.
' Monitors progress and performance of all projects to include quality of services, timelines of deliverables, compliance with regulatory requirements, and adherence to financial targets.
' Collaborates with TMHRI and functional managers to develop standardized tools and resources necessary for conduct of clinical research projects.
' Collaborates with TMHRI and Human Resources to develop training programs regarding key clinical topics for personnel conducting clinical research at The Methodist Hospital.
' Serves as a leadership resource for Faculty, TMHRI leadership, and personnel regarding the operational aspects of clinical research. Mentors and trains functional managers involved in the conduct of clinical research.
' Provides consultation, liaison, and administrative coordination between investigators and ancillary departments, research subjects, sponsoring organizations, and/or regulating bodies.
' Directs and manages the efforts of functional manager groups and clinical research personnel to include hiring, performance management, scheduling of work assignments, disciplinary action, promotions, and transfers.
' Defines and communicates job descriptions, core competencies, and performance standards and expectations.
' Coordinates regular research meetings to communicate departmental and organizational activities, goals, and policies.
' Collaborates with TMHRI to develop and implement orientation programs for new clinical research employees, continuing education, and professional development.
' Establishes accurate and consistent productivity expectations and revise as needed. Makes recommendations regarding staffing requirements to meet departmental needs and achieve maximum productivity.
' Assists with preparation of budgetary forecasts for clinical research revenue and expenses on an annual basis.
' Monitors expenditure of funds relative to budgetary targets for all trials on an ongoing basis. Ensures that variances are identified and communicated to appropriate personnel in a timely manner. Facilitates efforts to implement appropriate interventions. Identifies actual or projected variances and advise Administrative Leadership as appropriate.
' Ensures appropriate involvement and input of functional managers and Grants and Contracts in the development and negotiation of trial budgets and contracts.
' Collaborates with administrators and financial personnel on preparation of project reports to and TMHRI leadership regarding the financial and overall performance of individual projects.
Business Development and Marketing:
' Supports business development efforts by serving as a primary operational representative, maintaining and responding to inquiries regarding operational activities.
' Provides direction and input in the development of operational plans for new projects and proposals as well as collaborations and outsourcing.
' Represents the operational capabilities of AOCT in discussions with sponsors regarding potential clinical research projects.
' Provides input to functional groups regarding resource needs for potential and newly awarded clinical research projects.
' Attends national scientific meetings and investigator meetings annually. Serves on national scientific advisory committees and presents data as requested.
Bachelor's degree required.
Master's degree strongly preferred.
Minimum of 10 years of experience in clinical trial operations in an academic medical center, or in the pharmaceutical, medical device, biotechnology, or contract research industry.
Minimum of 5 years of experience managing professional/technical/clinical staff. Prefer experience in a variety of therapeutic areas.
Multi-site management experience required.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
' Current Texas RN licensure preferred.
' Research Certification required (CCRA , CCRC or equivalent)
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
' Experience planning and developing process for implementation of multi-center research projects.
' Requires strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
' Ability to make administrative and procedural decisions and judgments on sensitive, confidential issues.
' Requires highly effective time management skills.
' Requires ability to direct and train employees, to include organizing, prioritizing, and scheduling of work assignments.
' Ability to develop and deliver presentations.
Houston Methodist - 2 years ago