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Form of workThe Contract Manager, Clinical Trials is responsible for regional program administration and daily operational oversight for multiple, concurrent Clinical Trials for patients with extensive Long COVID symptoms. Given this new regional role, previous start-up experience with multiple Clinical Trials is essential. Initial Clinical Trials include the RECOVER observational study (funded by NYU-NIH), related concurrent research RECOVER Clinical Trials (Duke University CT-DCRI - NIH) and various federally-funded programs such as AHRQ, etc. This role functions in a dynamic, highly matrixed dyad management structure with multiple principal investigators across State of Arizona, to include primary RECOVER studies (MPIs Drs. Nikolich, Lee-Ianotti, Reiman & Parthasarathy), affiliated program staff and collaborative regional clinical network sites. This position also requires extensive expertise and daily working knowledge of clinical trial program compliance and will oversee all related regional regulatory requirements including IRB and audits. Additionally, this new role is responsible for all programmatic aspects of clinical trial network including, staff on-boarding, training, documentation, and primary communications lead with sponsoring organizations including NYU-CRC, Duke CT-DCRI, & NIH.
This position will direct an initial start-up team of 5-7 staff and, through advanced member engagement and annual enrollment targets, grow the program to include an extensive research network of clinical research coordinators, research RNs, clinical research assistants, data specialists, study startup project coordinators, program managers, and Clinical Trials senior staff. The Contract Manager, Clinical Trials will also develop annual objectives and key metrics to be achieved with overall responsibility for program success including achievement of patient enrollment targets.
Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to UA recreation and cultural activities; and more!
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Duties & Responsibilities- Direct regional program administration and daily operational oversight of new clinical trial research network for Long COVID patients, initially RECOVER observational study, affiliated RECOVER Clinical Trials and thru achievement of annual growth targets, new Clinical Trials sponsored in conjunction with Aegis.
- Co-responsibility shared with highly matrixed program team PI's to secure new, additional Clinical Trials to grow the clinical trial research network.
- Provides primary accountability for all programmatic and operational start-up activities for each new clinical trial.
- Develops and directs innovative and strategic approaches for performing new types of studies from a technical research and operational standpoint.
- Develop annual growth plan with overall responsibility to achieve all targets, milestones and metrics for patient enrollments in all clinical research trials including each new clinical trial.
- Manages all outreach efforts and initiatives to ensure successful program growth.
- Accountability to review specific budgets and contracts, monitor quality across all sites, develop training materials for clinical and administrative teams, develop reports & analytics that support key initiatives and strategies, develop and review SOPs, support day to day operations and problem solve clinical and administrative situations.
- Direct periodic meetings to monitor on-going and new start-up Clinical Trials and related communications with sponsoring entities, PI's and infrastructure support departments including compliance, quality, legal, regulatory and finance.
- Develop and maintain clinical trial network visual management system and data dashboards, including production/dissemination of monthly, quarterly and annual reporting.
- Participate in development and execution of operating unit health services research by assisting with advocacy efforts at local and national level activities.
Knowledge, Skills, and Abilities (KSAs):
- Knowledge and expertise in principles, practices and theories across multiple professional disciplines.
- Bachelor's degree or equivalent advanced learning attained through professional level experience required.
- Seven (7) years of related work experience, including three (3) years of managerial experience, or equivalent combination of education and work experience.
- Previous experience managing and leading a multi-site clinical trial research network.
- Ten (10) years of related work experience specific to Clinical Trials and new trial start-ups, including five (5) years of managerial experience, or equivalent combination of education and work experience.
- Experience in leading a multi-disciplinary, highly matrixed team, project, program, or function in a research and/or clinical arena.
- Experience in managing research operations that includes interfacing with healthcare systems and managing financial aspects of research and/or clinical operations.
