Regional Director of Clinical Research (Tucson)

Arizona Liver Health•Tucson, AZ

5h•$135,000 - $160,000•Onsite

About The Position

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.

Requirements

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.
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)
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
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.

Responsibilities

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 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.)
Supervisory responsibilities
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