Regional Director of Clinical Research position at Arizona Liver Health (ALH), responsible for driving high standards of care and advancing medical innovation through clinical trials, ensuring patient safety and regulatory compliance.
Requirements
- Develops and implements standards and guidelines for clinical research
- Assures the strategic vision, direction, and management of clinical research function
- Identifies and mitigates program risks proactively
- Critically reviews protocols and advises sponsors on changes
- Develops a working knowledge of FDA requirements for study development
- Develops standard operating procedures and processes to create best overall guidelines
- Oversees the overall evaluation and development of drugs or healthcare solutions
- Provides academic and administrative leadership
- Collaborates with Budget and Contracts Team to develop financially successful research projects
- Represent the company in research efforts and partnerships
- Builds strong relationships with vendors and collaborates with Business Development (BD) to build strategic pipelines of research studies
- Identifies business needs and collaborates with senior leadership to create strategic plans to increase patient volume and revenue
- Identifies and recruits high-caliber senior research staff fit to the strategic objectives
- Fosters a transparent environment encouraging strong partnerships and mutual trust between teams, sub-teams, and leaders
- Ability to establish work priorities and set realistic goals, meet deadlines, and organize a work environment ensuring efficient team participation
- Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP, and company SOPs
- Ability to fill in on behalf of research managers and all direct report positions
- Identifies business and employee risks and collaborates with appropriate parties to find sound resolutions
- Adhere to assigned spending budget from the Finance team and provide regular communication regarding spending needs
- Collaborate with operations and HR to develop, document, and assign metrics for each direct report
- Holds manager(s) accountable for performance of sites and individuals to achieve assigned Key Performance Indicators (KPIs)
- Partner with the CEO to establish the vision and strategic planning for all research at ALH and ACT
- Train/retrain/onboard new research staff with annual retraining as needed
- Review weekly site screening and clinic volume to meet and/or exceed goals
- Regulatory and/or Quality Assurance/Quality Control duties at site as needed
- Report regularly to executive team members and other relevant departments on status of Research Operations and performance
- Maintain effective and positive working relationships with patients, sponsors, providers, and employees
- Troubleshoot and resolve research, protocol, and SOP issues
Benefits
- Health, Dental, Vision (with HSA plans and employer contribution)
- 4 weeks PTO
- 5 days Sick Time
- 7 Company Paid holidays + 2 Paid Half-days
- 401K with up to 6% company match
- Short & Long Term Disability
- Educational Assistance
- Shared company vehicles for required travel
