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Director Clinical Research
2 months ago
Insight Global is looking for Administrative Research Director at a Major Health system in the Charleston, SC area. This person will be specifically involved in the Cancer Research Department.
The Administrative Director role requires knowledge in FDA regulations and ICH Good Clinical Practice to ensure that IITs are conducted in the highest quality and compliant manner that protects patient safety and data integrity. In collaboration with the scientific director and leadership, the Administrative Director will lead and mentor a team of CRAs who facilitate the development and successful completion of IITs from concept to close-out.
35% of this role will be IIT Portfolio Management
This role will work with the Research Programs and clinical leaders in the development and completion of all investigator-initiated treatment trials and other IITs managed by the CTO. He/she will serve as the administrative chair of the executive board that oversee the trial pipeline of clinical trials derived from members and science. The role will lead the teams to provide efficient and high-quality activation services and sponsor maintenance activities. The Administrative Director will track all IIT projects, monitor performance metrics, and effectively address or escalate issues to executive leadership. He/she must know clinical trial operations standards, budget development and research finance billing compliance, and local IRB, DSMC, and FDA policies and procedures. Project management skills are required to track all procedures from concept to completion. Shares findings with the CTO Director and assists in presenting information and initiatives at that Clinical Research Executive Committee, Leadership meetings and monthly Research Program meetings.
35% Fiscal Administrative Management -
The Administrative Director manages a $1 million annual budget and oversees IIT study accounts for clinical trials. Key responsibilities include developing study budgets, negotiating contracts, assisting with funding proposals, and ensuring compliance with research billing standards. The role involves collaboration with internal and external stakeholders to secure resources, overseeing fiscal activities, and supporting procurement and budget management for professional services. Additionally, the director works with finance teams to ensure proper invoicing and reporting for NIH grants.
25% Program Development:
The Program Development role involves overseeing human resources, quality assurance, process improvement, and strategic planning. Responsibilities include hiring, evaluating, mentoring, and training staff, developing policies and procedures, and maintaining compliance with regulations. The role also involves creating a quality assurance program, monitoring compliance, and implementing corrective actions. Collaboration with various institutional partners is essential to ensure policies meet regulatory standards. Additionally, the role requires staying updated on trends and developing strategic plans to enhance the program and support the growth of the IIT portfolio.
This position requires:
- Bachelor's Degree
- 5 years minimum of relevant clinical trial management experience
- Previous Oncology Clinical research experience
