Human Protections Specialist

University of New Mexico • Albuquerque, NM

39d • Hybrid

About The Position

The University of New Mexico Cancer Center Clinical Research Office is seeking a Human Protections Specialist to join the Quality Assurance Department. This position plays an important role in supporting the ethical, compliant, and high-quality conduct of human subject research across the clinical research program.
The Human Protections Specialist participates in planning, organizing, and conducting internal monitoring and quality assurance reviews of IRB-approved Oncology research studies to ensure compliance with applicable federal regulations, institutional policies, and sponsor requirements. These activities support ongoing audit readiness and help ensure research teams are prepared for external reviews by sponsors, cooperative groups, and regulatory authorities. Through monitoring activities, the position identifies trends, areas for improvement, and opportunities to strengthen research processes to protect human research participants and support high-quality clinical trial conduct.
This role also supports the development and implementation of corrective and preventive action (CAPA) plans in response to audit findings, deviations, or compliance concerns. The position works collaboratively with investigators and research staff to provide guidance on regulatory requirements and best practices, promote continuous quality improvement, and strengthen adherence to federal regulations governing human subjects research.
In addition, the Human Protections Specialist assists with the development and delivery of training and educational initiatives for faculty, staff, and research personnel. These efforts focus on topics such as Good Clinical Practice (GCP), human subject protections, regulatory compliance, and institutional quality improvement initiatives designed to enhance communication of audit findings, monitoring trends, and best practices across the research program.
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

Requirements

• Bachelor's degree in Nursing, Biomedical Science, or closely related field
• at least 3 years of experience directly related to the duties and responsibilities specified
• Certification as Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or Certified IRB Professional (CIP) must be obtained within 1 year of date of hire.

Nice To Haves

• Prior auditing experience, either in clinical research or health related field. Demonstrated ability and experiencing completing audits and quality improvement assessments.
• Knowledge of the mandates, operations, and organization of an Institutional Review Board.
• Knowledge of patient care charts, quality control practices and procedures within a hospital, patient care, registry environment, or strong knowledge of data collection techniques.
• Knowledge and understanding of FDA and other Federal and State laws, regulations, guidelines, for the conduct, documentation, and reporting of human subject research.
• Experience and understanding of federal regulations related to clinical research compliance and reporting.
• Excellent problem solving and critical thinking skills.
• Word processing and/or data entry skills.
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to communicate effectively, both orally and in writing.
• Ability to gather data, compile information, and prepare reports.

Responsibilities

• participates in planning, organizing, and conducting internal monitoring and quality assurance reviews of IRB-approved Oncology research studies to ensure compliance with applicable federal regulations, institutional policies, and sponsor requirements
• supports the development and implementation of corrective and preventive action (CAPA) plans in response to audit findings, deviations, or compliance concerns
• works collaboratively with investigators and research staff to provide guidance on regulatory requirements and best practices, promote continuous quality improvement, and strengthen adherence to federal regulations governing human subjects research
• assists with the development and delivery of training and educational initiatives for faculty, staff, and research personnel

Benefits

• This is a benefits eligible position. The University of New Mexico provides a comprehensive package of benefits including medical, dental, vision, and life insurance. In addition, UNM offers educational benefits through the tuition remission and dependent education programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level