The ITM Clinical Research Regulation and Training Lead is responsible for planning, directing, coordinating, and managing the daily operations of the ITMâ™s Regulatory Knowledge and Support, and Workforce Development programs, including financial, meetings/events, and program services.This position ensures the stability, success and growth of these programs by focusing on the accomplishment of the programsâ™ strategic aims. The ITMâ™s Regulatory Knowledge and Support Program seeks to reduce the time from a clinical research studyâ™s concept to completion at all ITM institutions by establishing and/or refining parallel pathways through institutional regulatory components (e.g., grants management, conflictâofâinterest review).
The ITMâ™s Workforce Development Program seeks to improve the training of clinical research study teams across ITM institutions by maintaining a comprehensive catalogue of research training, ensuring the alignment of training with national competencies, identifying training gaps and creating new training opportunities to fill those gaps, and by refining and aligning the career pathways for clinical research staff. This position requires inâdepth knowledge and experience of clinical research regulations/operations and the training of clinical research staff in an academic health/medical setting. The Lead uses broad and deep knowledge of clinical research and training, best practices in the field, and awareness of evolving internal or external issues both nationally within the CTSA consortium and locally across the ITM institutions to improve the work of the programs and the services offered to investigators, study teams, and the public. This position solves complex problems and/or takes a new perspective using existing solutions. The Program Lead largely works independently, receiving minimal guidance, and acts as a liaison and resource on clinical research regulatory/operations and training matters for colleagues throughout the ITM. Meetings with community organizations, part of the responsibilities of this position, frequently take place on evenings/weekends.
This at-will position is wholly or partially funded by extramural funds (e.g., grant, gift, endowment) which is renewed under provisions set by the grantor. Employment will be contingent upon the continued receipt of these extramural funds and your satisfactory job performance. If the position is eliminated due to the discontinuation of extramural funding, you will be given a minimum of one pay period's written notice (if exempt: 30 days, if non-exempt: 2 weeks), or pay in-lieu of notice.
Uses inâdepth knowledge and experience to administer the delivery of programsâ™ services to program participants.
Develops and implements the programsâ™ work plans, assuring adherence to programsâ™ aims.
Develops and maintains a comprehensive inventory of clinical research regulatory operations and training initiatives across ITM institutions.
Aligns training and career development of clinical research professionals across ITM institutions
Develops and implements new training and programs to meet emerging/unmet needs.
Sets and communicates program priorities and performance standards and assesses operations using these criteria.
Plans and conducts quality assurance reviews and recommends changes as appropriate.
Establishes and tracks performance metrics, showing impact of programsâ™ activities
Drafts and submits programsâ™ progress reports
Provides regular updates and presentations on program activities and accomplishments, as needed
Manages the programsâ™ expenditures and budget, and recommends or makes budgetary recommendations.
Interacts with faculty, researchers, external stakeholders, and staff for committee work or information.
Manages ongoing program work, ensures communication and fosters accountability through regular meetings of the programsâ™ leadership: tracking agendas, action items, decisions, and minutes.
Coordinates the work of the programsâ™ participants across ITM institutions.
Together with program leadership, participates in the governance of the ITM, ensuring the dissemination of program activities and accomplishments and coordinating program activities with other ITM clusters.
Ensures participation in national CTSA activities, including applicable Domain Task Forces and Work groups.
Ability to work as part of collaborative team as well as autonomously
Demonstrated accuracy, precision and attention to detail
Strong organizational and project management skills
Expertise in Microsoft Office software applications
Excellent written and verbal communication skills, including presentation skills
Familiarity with administration within a complex research university environment
Excellent interpersonal skills
Ability to handle public contacts with courtesy, clarity, and diplomacy
Ability to maintain calm and courteous demeanor and to work productively despite heavy workload, competing priorities, complex problems, and tight deadlines
Excellent problemâsolving skills
Ability to use appropriate resources to resolve an issue
Ability to follow an issue through to resolution
Education, Experience and Certifications:
Bachelor's degree is required in a related field.
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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