Position Classification Description

Position Class Code / Title: A8031 / Dir,Clinical Trials/Affiliates
Recruitment Tier: Tier 1
FLSA: Exempt
Grade: 18

This is a description of a Staff Position Classification. It is not an announcement of a position opening. To view descriptions of current openings, please go to UNMJobs and Search Postings to view positions that are currently accepting applications.

The following statements are intended to describe, in broad terms, the general functions and responsibility levels characteristic of positions assigned to this classification. They should not be viewed as an exhaustive list of the specific duties and prerequisites applicable to individual positions that have been so classified.

Summary

Directs and manages the Clinical Research Office within the UNM Comprehensive Cancer Center (UNM CCC), to include the Clinical Protocol Data Management & Informatics Shared Resource (CPDM&I) designated by the National Cancer Institute (NCI). Ensures alignment with the strategic vision, direction and management of all clinical research and clinical trial operations for the Clinical Research Office and UNM CCC. Oversees all aspects of clinical trials management for NCI-sponsored, pharmaceutical-sponsored, and investigator-initiated trials, to include legal review, institutional review board approvals, contracting, scientific and protocol review, compliance, auditing and monitoring, quality control, and financial management and reporting.

Duties and Responsibilities

  1. Establishes, maintains, and oversees the multifaceted and integrated processes and procedures of the UNMCCC Clinical Research Office, ensuring adherence with University policies, and all institutional, state, and federal auditing, monitoring, reporting, and compliance requirements for the conduct of cancer clinical trials and cancer clinical research involving human subjects.
  2. Identifies and solicits potential new clinical trials and participant sites, in conjunction with faculty and affiliated physicians; establishes and implements participant and sponsor agreements for all participants, as needed.
  3. Ensures fiscal control for all activities across the organizational unit; develops and manages budgets, performs long-range financial and business planning, develops metrics to measure the ongoing status of the unit, and develops and prepares monthly operating reports.
  4. Oversees the supervision of personnel, which includes work allocation, training, promotion, enforcement of internal procedures and controls, and problem resolution; evaluates performance and makes recommendations for personnel actions; motivates employees to achieve peak productivity and performance.
  5. Responsible for the monitoring, oversight and review of all clinical trials conducted at UNMCCC and affiliate sites; develops and implements policies and procedures that are consistent with, the School of Medicine (SOM) Human Research Protections policies, Federal Drug Administration (FDA) Good Clinical Practices guidelines, and all other applicable institutional, state and federal auditing and compliance requirements.
  6. Interacts with pharmaceutical and clinical research organization leaders to promote the UNMCCC and the CRO/CPDM&I and gain access to appropriate clinical trials; interacts with faculty, staff, and other cancer-related organizations to raise awareness of clinical trial offerings.
  7. Oversees and coordinates the development, negotiation, implementation, and administration of contracts and budgets with clinical trial sponsors, vendors, and the SOM HRRC for constituencies wishing to access UNMCCC services.
  8. Develops marketing and communication plans designed to attract pharmaceutical companies into trial sponsorships with the UNMCCC CRO/CPDM&I and the statewide network; works with UNMCCC Marketing and Communications to develop strategies and resources to raise general awareness of clinical trials and to assist the primary site and affiliates in their subject recruitment efforts.
  9. Directs the establishment of continuing education and training programs for CRO/CPDM&I staff and UNMCCC physicians and research staff, ensuring that all educational requirements are met.
  10. May serve as Executive Director of the New Mexico Cancer Care Alliance overseeing all cancer clinical trials activities in a statewide network of UNM community-based affiliate sites, member institutions, and groups.
  11. Performs miscellaneous job-related duties as assigned.

Minimum Job Requirements

  • Master's degree in Healthcare or Business Administration; at least 7 years of experience directly related to the duties and responsibilities specified.
  • Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis.

Knowledge, Skills and Abilities Required

  • Ability to work under pressure and meet deadlines.
  • Ability to use independent judgment and to manage and impart confidential information.
  • Advanced working knowledge of public healthcare operations gained at a management level.
  • Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures.
  • Skill in organizing resources and establishing priorities.
  • Demonstrated program development and management skills.
  • Knowledge and understanding of all laws, regulations, guidelines, and best practices related to the conduct of human subject clinical trials.
  • Knowledge of strategic communications and marketing concepts, principles, methodology and techniques.
  • Skill in the formulation, negotiation, and establishment of complex, integrated contractual arrangements.
  • Knowledge of the ethical considerations and issues surrounding the conduct of invasive and non-invasive human research.
  • Strong interpersonal skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Organizational planning, structuring, and staffing skills.
  • Skill in financial planning and fiscal management.
  • Human resources management skills.

Conditions of Employment

  • Successful candidate must submit to post-offer, pre-employment physical examination and medical history check.
  • Employees in this job title are subject to the terms and conditions of an employment contract. Employment contracts are typically subject to review and renewal on an annual basis.
  • Employees who provide services or work in patient care or clinical areas are required to be in compliance with the University's influenza vaccination requirement.

Working Conditions and Physical Effort

  • No or very limited physical effort required.
  • No or very limited exposure to physical risk.
  • Work is normally performed in a typical interior/office work environment.

The University of New Mexico provides all training required by OSHA to ensure employee safety.

Revised Date: 09/14/2020