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VP of Clinical Research Operations 

Peoria, AZ

 

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 Summary:

The VP of Clinical Research Operations, will oversee all clinical trial operations across multiple sites, ensuring excellence in site readiness, workflow planning/efficiency, and successful clinical trial execution. As part of the executive leadership team, this position will collaborate with both internal and external stakeholders to help scale operations, drive performance metrics, and aid maintaining regulatory compliance. The VP will deliver on tactical objectives that align with company strategies on quality, efficiency, and growth, while leading initiatives that position the organization as the premier clinical research site for Phase II-III research.

Job Title: VP of Clinical Research Operations 

Location: Onsite (Peoria or Tucson preferred) (relocation package offered)

Reports To: ​Chief Executive Officer (CEO)

Compensation: $180,000 - $200,000

Status: Full-time, Salary, Exempt

Essential job functions/duties 

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.  

Operational Leadership and Efficiency

  • Develop and implement streamlined workflows across all Phase II-III clinical trial sites
  • Identify operational gaps and implement scalable solutions to improve efficiency and quality of trial execution
  • Lead process mapping, key performance indicator (KPI) tracking, and root case analysis to enhance site performance and accountability 
  • Ensure that assigned departmental budgets are adhered to each year with regards to supply, staffing, bonuses/pay

Clinical Trial Execution and Compliance

  • Execute seamless cross-functional collaboration from contract execution, to start-up, to regulatory compliance and close-out
  • Develop and directly oversee the project management, patient recruitment strategy, and data integrity to deliver results
  • Ensure site adherence to all study protocols, GCP guidelines, and regulatory requirements and follow through on compliance issues to ensure corrective action takes place in a timely manner

Team Management and Development

  • Build and lead a high-performing team of clinical research professionals and leaders including directors, sr. managers, site managers, and support staff
  • Develop and deliver consistent training programs for new and existing clinical research staff that promote performance standards, growth, compliance, and consistency across all sites
  • Foster a culture of ALH/ACT’s core values ensuring that the organization’s mission and vision are at the forefront of both individual and site-level’s goals

Strategic Leadership and Organizational Growth

  • Collaborate with executive leadership to shape strategic goals for Phase II-III clinical operations and trial portfolio growth
  • Evaluate and integrate new technologies to enhance operational efficiency
  • Establish new and nurture existing vendor and CRO relationships to help secure high-enrolling studies in collaboration with the business development department
  • Assess departmental organizational chart in collaboration with the HR department to ensure a functional organizational structure; includes succession and staff planning, internal mobilization, and evaluation of current position and job functions.

Supervisory responsibilities

  • Hire, train/onboard, oversee performance, and ensure smooth transitions of senior level research leaders into new roles or new sites for Phase II-III research
  • Conduct timely new hire evaluations, monthly one-on-one meetings, and biannual evaluations for assigned direct reports
    • Ensure that direct reports are also completing these tasks on time for their team members
  • Collaborate with HR department to address both individual and site level performance and productivity issues
  • Execute assigned leadership administrative tasks including the approvals of expenses, time off, ancillary pays (on-call timesheets) for assigned direct reports and ensure that direct reports are executing in a timely manner for their team members
  • Delegate operational tasks, goals, and KPIs that align with company strategy
  • Ensure that team members are properly trained and prepared to execute new projects/clinical trials
  • Ensures that operations team are properly communicated with regarding compliance issues and oversees that corrective actions are executed to comply with all research regulations

Knowledge/Skills/Abilities Required

  • Demonstrated success in managing multisite clinical research operations with deep understanding of clinical trial processes and workflows
  • Deep knowledge of FDA regulations, ICH-GCP, and trial lifecycle management
  • Proven ability to lead cross-functional teams and implement process improvement measures
  • Strong communication, negotiation, and stakeholder management skills
  • Strong ability to work independently with little supervision and direction/guidance
  • Excellent interpersonal and problem-solving skills

Education, credentials, and/or trainings required

  • Bachelor’s degree required in health sciences, business administration, healthcare administration, or relevel field with at least ten (10) years of research experience and seven (7) years in senior leadership roles overseeing clinical research operations OR
  • A master’s degree in business administration or related field with at least five (5) years of senior leadership experience in a clinical research setting overseeing operations
  • APP (Nurse Practitioner or Physician Assistant) with at least (10) years of experience in clinical research operations preferred
  • GCP training and execution of all other regulatory/compliance trainings as required for clinical research (can be completed upon hire)
  • Previous experience or trainings in clinical research required either as a clinical research coordinator, regulatory/compliance specialist, patient recruitment coordinator, or site manager

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
  • Ability to travel and operate a vehicle at least 40% of the time each week

Travel Requirements

  • Interoffice travel will be required to ensure leadership presence; overnight travel may be required from time to time to ensure operational efficiency for large clinical trial projects
  • Travel is anticipated to be approximately 40% -- (this is defined as 2 days per week to sites)

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)

Our company requires COVID-19 vaccinations for all current and future employees. Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation.

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.

 

 

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