Mgr,Clinical Trials Operations

This position, under indirect supervision, will be responsible for managing and overseeing the operations of research studies conducted within the Division of Neonatology, which include protocol administration, clinical coordination activities, and regulatory compliance oversight. This position also requires report preparation for funding agencies and relevant parties within UNM, training and mentoring coordinator staff, overseeing accuracy and progress toward goals, and participation in development and implementation of research support protocols.

The Neonatology Division will participate in several studies/trials and each study includes gathering detail information on very preterm and/or critically ill newborn infants, to include respiratory support, sepsis analysis, mortality outcomes and others. The Division also participates in a Network where trials are focused on the pediatric population. The position requires someone who is very detail oriented, is an independent worker and thinker as well as able to identify resources and learn quickly in new situations.

This position involves completion of duties in the following general areas, as well as other duties as needed for successful research protocol completion:

• Protocol Administration, including screening and recruitment of potential study candidates; overseeing and coordinating the research-related care and treatment of subjects; data collection, entry and editing in accordance with Neonatal Research Network and IdEA states protocols and requirements; coordinating services with other departments and agencies; and reporting of protocol deviations and adverse events.
• Clinical Coordination activities, such as serving as the liaison between investigators, clinical personnel, ancillary departments, research subjects, sponsoring organizations, and/or regulating bodies; educating staff regarding protocols; ensuring compliance with established research standards, applicable laws, regulations, policies, and procedural requirements.
• Regulatory compliance requirements, such as preparing IRB approval documents; assessing operational, financial, and material requirements for studies; developing budgets and funding mechanisms as appropriate; assuring compliance with FDA and other study regulators' requirements.

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.

• Previous experience coordinating research studies
• Previous experience with critically ill newborns
• Previous experience with education of health care providers
• Bilingual (Spanish speaking)

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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.