Regional Director of Clinical Research (Peoria)

About the role

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment. Job Title: Regional Director of Clinical Research Location: Peoria, AZ Reports To: CEO Compensation: $135,000 - $150,000 annually, depending on experience Status: Full-time, Salary, Exempt Essential job functions/duties Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Develops and implements standards and guidelines for clinical research under the direction of the Principal Investigator or sub-investigator. Responsible for assuring the strategic vision, direction and management of clinical research function. Identifies and mitigates program risks proactively. Critically review protocols and advise sponsors on changes. Become a scientific resource for other team members including familiarity with investigational drug mechanisms of action. Develop a working knowledge of the FDA requirements for study development, including when hepatic and renal impairment studies are required. Develop standard operating procedures and processes to create best overall guidelines Oversee the overall evaluation and development of drugs or healthcare solutions and oversee programs designed to prevent or treat disease, and more. Provides academic and administrative leadership. Collaborate with Budget and Contracts Team to develop financially successful research projects. In depth knowledge of working practices and industry best-practices. Represent the company in research efforts and partnerships; build strong relationships with vendors and collaborates with Business Development (BD) to build strategic pipelines of research studies for assigned sites. Identifies business needs and collaborates with senior leadership to create strategic plans to increase patient volume and revenue for the assigned region Identify and recruit high-caliber senior research staff fit to the strategic objectives Foster 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) for being met Partner with the CEO to establish the vision and strategic planning for all research at ALH and ACT and to ensure delivery of the strategic plan, particularly with respect to clinical research 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. Become a resource for regulatory questions after shadowing the compliance management team. This should include IRB submissions, learning IRB requirements, and all regulatory requirements for a new protocol and IND/NDA for sponsors. 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 --- advise Site Managers Develop SOPs and processes as appropriate for the operations of the site Assist in establishing and enforcing departmental standards Attend and present at scheduled meetings with research staff. Present new studies and site goals to the recruiting and APP teams (research and SOC). Direct/Assist with projects and tasks assigned by the VP of Research. Provide assistance with study protocol adherence as necessary. Ensure site staff completes assigned tasks Daily Clinical Research Operations Oversee the Research Site Managers or Assistant Managers. Resolve daily issues/concerns for the site and advise on any work quality conc

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