Regulatory Affairs Manager jobs in New Mexico

The University of New Mexico Cancer Center’s Clinical Research Office is recruiting for a Study Start Up and Regulatory Manager.  Reporting to the Director, Clinical Research Office/Executive Director, New Mexico Cancer Research Alliance, this position has primary responsibility for oversight of study start-up and regulatory compliance of the Clinical Research Office.  This position will manage all aspects of the study start up and regulatory pre and post activation procedures of NCTN, sponsor/industry, and investigator-initiated trials to deliver study outcomes within schedule, quality/compliance, and performance standards.  Contributes to operational excellence through process improvement, knowledge sharing, and implementation of new and/or revised standard operating procedures.  This position is responsible for directing the work of the Clinical Research office regulatory program and staff, manages resources and helps to plan and implement strategic direction for the department.

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 146 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 partner with community health systems statewide to provide cancer care closer to home. They treated 13,578 patients in 105,748 ambulatory clinic visits in addition to in-patient hospitalizations at UNM Hospital. A total of 1361 patients participated in cancer clinical trials, including 544 (40%) patients who participated in clinical trials testing new cancer treatments that include tests of novel cancer prevention strategies and cancer genome sequencing. The more than 102 cancer research scientists affiliated with the UNMCCC were awarded $36.2 million in federal and private grants and contracts for cancer research projects. Since 2015, they have published 930 manuscripts, and promoting economic development, they filed 136 new patents and launched 10 new biotechnology start-up companies. Finally, the physicians, scientists and staff have provided education and training experiences to more than 530 high school, undergraduate, graduate, and postdoctoral fellowship students in cancer research and cancer health care delivery. Learn more at http://cancer.unm.edu.

See the Position Description for additional information.

• National certification from Association of Clinical Research Professionals or Society of Clinical Research Associates is required to oversee Phase III clinical trials.
• New Mexico licensure as a Registered Nurse may be a requirement for some positions in this classification.

Successful completion of at least 60 college-level credit hours; 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.

·         Master’s degree in science or health related filed, and five years of experience in clinical research; comprehensive understanding of clinical research regulations and processes.

·         Strong organizational skills.

·         Strong written and oral communication skills.

·         Excellent problem solving and critical thinking skills.

·         Ability to manage multiple projects and priorities simultaneously.

·         Experience and understanding of federal regulations related to clinical research.

·         People management and staff training experience.

·         Strong leadership skills with the ability to implement through influence when required.

Only applications submitted through the official UNMJobs site will be accepted. If you are viewing this job advertisement on a 3rd party site, please visit UNMJobs to submit an application.

The University of New Mexico has implemented a mandatory COVID-19 vaccine requirement for UNM students and employees. For detailed information, visit https://bringbackthepack.unm.edu/vaccine/vaccine-requirement.html

Positions posted with a Staff Type of Regular or Term are eligible for the Veteran Preference Program. See the Veteran Preference Program webpage for additional details.

The University of New Mexico is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability, or any other protected class.

The University of New Mexico requires all regular staff positions successfully pass a pre-employment background check. This may include, but is not limited to, a criminal history background check, New Mexico Department of Health fingerprint screening, New Mexico Children, Youth, and Families Department fingerprint screening, verification of education credentials, and/or verification of prior employment. For more information about background checks, visit https://policy.unm.edu/university-policies/3000/3280.html. Refer to https://policy.unm.edu/university-policies/3000/3200.html for a definition of Regular Staff.