Regional Director of Clinical Research

About Us:

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 or VP of Clinical Operations

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.

Strategic Leadership & Operations

• Drive the overall direction and management of clinical research operations across assigned sites, partnering with the CEO and executive team to increase patient volume, revenue, and clinical outcomes.
• Develop, implement, and enforce standard operating procedures (SOPs) and industry best practices.
• Collaborate with Finance and Business Development to manage budgets, ensure financially successful projects, and build strategic pipelines.
• Act as the primary liaison and organizational representative for sponsors, vendors, and cross-functional departments.
• Track Key Performance Indicators (KPIs), mitigate risks proactively, and report regularly on Research Operations performance to executive leadership.

Daily Clinical Research Operations

• Ensure site-wide compliance with FDA CFR, GCP, and internal SOPs. Oversee IRB submissions, IND/NDA requirements, and QA/QC operations.
• Critically review protocols, advise sponsors on study design (including hepatic/renal impairment), and monitor adherence to study timelines.
• Assess study feasibility regarding site resources, labor costs, and potential risks (AEs, noncompliance). Troubleshoot protocol deviations and daily operational issues.
• Serve as the subject matter expert on investigational drug mechanisms and healthcare solution evaluations.
• Oversee the Research Site Managers or Assistant Managers.
• Resolve daily issues/concerns for the site and advise on any work quality concerns.
• Monitors adherence to protocols and study timelines.
• Completes Study Feasibility Forms in conjunction with study start-up team.
• Establishes departmental needs, supplies, staffing and equipment goals to continually improve the research process within the established guidelines of the institute.
• Serves as a liaison across assigned regional sites for research related activities.
• Acts as a liaison for clinical trial sponsors, vendors and sites.
• Develops and coordinates clinical trial and operational activities and manages the execution to ensure completion according to project timelines and budget across multiple locations.
• Ensure high quality clinical research conduct by supporting clinical research training, career development of research staff, and collaboration with compliance.
• Develop management systems and prepare for study initiation
• Assess study feasibility in terms of study's impact on site resources, labor cost, cost by procedure, potential for problems (such as serious AEs, noncompliance, willingness of subjects to participate, protocol deviations, etc.)

Team Leadership & Supervisory Duties

• Hiring and training new team members
• Timely execution of performance evaluations
• Mentorship and coaching to elevate skillsets of current team
• Plan both professional and personal goals with team members to ensure productivity and meeting assigned KPIs
• Delegate responsibilities among team members as needed to ensure efficiency
• Perform progressive disciplinary action and proper documentation in collaboration with Human Resources for team members as necessary
• Conduct site specific team building activities to engage employees
• Ensure high quality, high volume and efficient productivity.
• Work with Human Resources to oversee all relevant HR activities and strategies for developing staff in line with strategic goals of the organization.
• Identify training needs of team members.
• Ensure a working understanding of human resource management issues including: Workplace Health and Safety, Equal Employment Opportunity and Anti-Discrimination

Knowledge/Skills/Abilities Required

• A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
• Strong Interpersonal communication and customer service skills, both verbal and written. Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources.
• Strong organization, time-management, and leadership skills with ability to train others and help upskill leadership team members reporting under them
• Ability to provide all employees and research subjects with excellent service experience by consistently demonstrating professional decorum.
• Knowledge of FDA regulatory requirements is required. Has knowledge of commonly used concepts, practices and procedures within particular field. Rely on instructions and pre-established guidelines to perform the functions of the job.

Education, credentials, and/or trainings required

• Bachelor’s degree required in nursing, health sciences, or related field with at least five (5) years of clinical research experience in an operational leadership role OR
• APP (advanced practice provider), RN (registered nurse), or Foreign Medical Graduate with direct patient care experience and clinical leadership role in hospital or private practice setting for at least three (3) years
• Previous experience as a senior leader with high-level decision-making responsibilities required
• Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation and trial management)

Work environment

• Clinic setting

Physical demands

• Able to lift at least 25 lbs.
• Able to sit for long periods (at least 50%)
• Able to type and do computer work for long periods

Travel Requirements

• Some interoffice travel may be required with use of company vehicle or mileage reimbursement

Benefits & Perks:

• 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 (eligible to enroll after 90 days)
• Short & Long Term Disability
• Educational Assistance
• Shared company vehicles for required travel

Work authorization

Must have active and valid documentation and authorization to work in the United States for any employer (work sponsorship or work visa transfer not available)

EEO statement

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.

Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation