Program Specialist

University of New Mexico•Albuquerque, NM

4d•Hybrid

About The Position

Under indirect supervision, this position is responsible for the coordination, development, improvement and management of regulatory compliance and documentation activities governing pediatric oncology/hematology clinical research studies in accordance with Good Clinical Practice (GCP) guidelines, established UNM and IRB policies and procedures and government regulations. This role is responsible for facilitating the start-up and maintenance of clinical trials for the pediatric oncology research program, working with study sponsors, site staff and ancillary departments and organizations responsible for the conduct of the study. This role will maintain regulatory binders/e-binders and study-level documents in “audit-ready” status for assigned trials ensuring compliance with all relevant regulations and requirements. This person will be responsible for educational and technical assistance to research staff on IRB and regulatory issues and requirements. The University of New Mexico Comprehensive Cancer Center is the Official Cancer Center of New Mexico and the only National Cancer Institute-designated Cancer Center in a 500-mile radius. Its 136 board-certified oncology specialty physicians include cancer surgeons in every specialty (abdominal, thoracic, bone and soft tissue, neurosurgery, genitourinary, gynecology, and head and neck cancers), adult and pediatric hematologists/medical oncologists, gynecologic oncologists, and radiation oncologists. They, along with more than 600 other cancer healthcare professionals (nurses, pharmacists, nutritionists, navigators, psychologists and social workers), provide treatment to 65% of New Mexico’s cancer patients from all across the state. And they partner with community health systems statewide to provide cancer care closer to home. In 2024 they treated more than 15,000 patients in almost 105,000 ambulatory clinic visits in addition to in-patient hospitalizations at UNM Hospital. A total of 2,075 patients participated in cancer clinical trials to study new cancer treatments that include tests of novel cancer prevention strategies and cancer genome sequencing. The more than 123 cancer research scientists affiliated with the UNM Cancer Center were awarded $38.3 million in federal and private grants and contracts for cancer research projects. Since 2015, the physicians, scientists and staff have provided education and training experiences to more than 750 high school, undergraduate, graduate, and postdoctoral fellowship students in cancer research and cancer health care delivery. Website: unmhealth.org/cancer See the Position Description for additional information.

Requirements

High school diploma or GED; at least 6 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.

Nice To Haves

Bachelor of Science (BS) degree, in a health-related field preferred
2 years research, oncology or related experience or certified by the Association of Clinical Research Professionals (ACRP) or SoCRA
Knowledge of the principals, procedures, and ethical considerations surrounding the conduct of invasive and non-invasive human research.
Knowledge of FDA and OHRP, regulations and guidelines pertaining to the performance, documentation, and reporting of human research

Responsibilities

Coordination, development, improvement and management of regulatory compliance and documentation activities governing pediatric oncology/hematology clinical research studies in accordance with Good Clinical Practice (GCP) guidelines, established UNM and IRB policies and procedures and government regulations.
Facilitating the start-up and maintenance of clinical trials for the pediatric oncology research program, working with study sponsors, site staff and ancillary departments and organizations responsible for the conduct of the study.
Maintaining regulatory binders/e-binders and study-level documents in “audit-ready” status for assigned trials ensuring compliance with all relevant regulations and requirements.
Providing educational and technical assistance to research staff on IRB and regulatory issues and requirements.