Trial Innovation Network Manager
Serves as the primary interface to the national CTSA Trial Innovation Network (TIN), comprised of three organizational partners: the CTSA Program Hubs, the Trial Innovation Centers (TIC) and Recruitment Innovation Center (RIC). This role also serves as a primary point of contact for new and existing researchers during the initiation and ongoing conduct of multicenter clinical trials and oversees the research team which moves clinical research projects through its entire lifecycle, from conception, through initiation and data collection, to analysis and publication.
- Works with the national CTSA Trial Innovation Network (TIN) to leverage the expertise of the local Clinical Translational Science Center (CTSC) and improve multicenter clinical trial operational innovation and excellence.
- Assists in study start-ups. Establishes workflows and a working model for investigators to use external IRBs, ensuring the IRB is notified of any studies that will receive review and the execution of IRB reliance agreements.
- Assists investigators with a standard agreement, cIRB, recruitment sites, regulatory support, project management, enrollment metrics, development of consent forms, site selection and trial initiation at those sites, and with recruitment plans and tools.
- Collaborates with the CTSA national Recruitment Innovation Center (RIC) to enhance recruitment and retention at site(s), informing interested participants of trial opportunities and assisting in the recruitment of eligible participants.
- Represents the CTSC in national forums and disseminate best practices to the broader CTSA community as appropriate.
- Develops Standard Operating Procedures (SOPs) & disseminates to the research community across partner institutions to ensure compliance with TIN policies & procedures. Engages research team members to inform them of new initiatives as they are implemented
- Works with investigators to ensure efficient conduct of all TIN multicenter studies, from protocol development through study completion, including development of study timelines.
- Manages the research team and supervises day-to-day activities, including: training and orientation; evaluating and monitoring work performance; overseeing management of schedules and workloads.
- Works with the Participant and Clinical Interactions (PCI) Component on shared strategic initiatives, such as cost recovery of clinical research resources, protocol monitoring and reviews to address barriers to enrollment.
- Performs other duties as assigned.
- Proficiency in using various Microsoft Office applications. Familiarity with Internet applications.
- Ability to effectively interface with all levels of management.
- Effective oral, written, communication, presentation and interpersonal skills.
- Must work and communicate effectively with both internal and external customers
- Demonstrated knowledge of regulatory and data management aspects of clinical research
- Ability to work within a team environment as well as independently
- Strong time management and organizational skills.
- Ability to identify, analyze and solve problems, ability to work well under pressure.
Master’s degree in relevant field may substitute for some experience. Minimum 5 years of research experience in an academic health center with exposure to team research environments at all levels. Relevant certifications in clinical research – i.e. Certified Clinical Research Professional (CCRP) by the Society of Clinical Research Associates (SoCRA) or Certified Clinical Research Coordinator (CCRC) by the Association of Clinical Research Professionals (ACRP) is highly desired. Experience managing multicenter clinical trials in an academic health center preferred. Working knowledge of social media networks such as Facebook and Twitter highly desirable.