Mgr,Clinical Trials Operations

University of New Mexico • Albuquerque, NM

17d • Onsite

About The Position

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.

Requirements

• Successful completion of at least 60 college-level credit hours
• at least 7 years of experience directly related to the duties and responsibilities specified.
• National certification from Association of Clinical Research Professionals or Society of Clinical Research Associates is required to oversee Phase III clinical trials.

Nice To Haves

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

Responsibilities

• 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
• 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

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed