Mgr,Clinical Trials Operations

University of New Mexico; Albuquerque (NM); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading educational institution is seeking a Manager for Clinical Trials Operations in Albuquerque, NM. This role oversees Phase III clinical trials and manages clinical and laboratory research operations. The ideal candidate will have extensive experience in clinical research oversight and national certification in clinical research. This position offers competitive benefits, including medical, dental, vision, and educational assistance.

Benefits

Comprehensive medical, dental, and vision insurance

Tuition remission

Dependent education programs

Qualifications

• Successful completion of at least 60 college-level credit hours.
• At least 7 years of experience in clinical research.
• New Mexico licensure as a Registered Nurse may be required for some positions.

Responsibilities

• Oversee Phase III clinical trials and manage research operations.
• Coordinate investigator-initiated protocols and consent processes.
• Lead large volume projects delivering high quality data.

Skills

Experience in clinical research oversight

Knowledge of FDA, IRB, ICH-GCP regulations

Expertise in HPV and cervical cancer

Project management skills

Experience in quality control and assurance

Knowledge of data analysis

Administration process oversight

Experience in clinical trial planning

Education

60 college-level credit hours

National certification as Clinical Research Coordinator or Professional

Tools

Banner

Chrome River

LoboMart

Job description

Mgr, Clinical Trials Operations

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.

Qualifications

• 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.
• Experience in clinical and laboratory research operations oversight, including investigator and staff training in compliance with all FDA, IRB, ICH-GCP regulations.
• Experience in Population-based registries or large-scale clinical data management, preferably in HPV, cancer prevention or women's health.
• Experience in demonstrated knowledge in HPV, cervical cancer and vaccination programs, including public health prevention strategies.
• Experience in developing and orchestrating investigator-initiated protocols, informed consents, source documents, organized tracking systems for both laboratory and clinical trial studies in compliance with all regulatory entities.
• Experience coordinating the execution of large volume projects with a team of laboratory and clinical researchers delivering high quality data to external funding agencies.
• Experience in implementation of quality control / quality assurance development in the laboratory and clinical research, industry or medical diagnostic settings ensuring and maintaining audit-ready condition of all clinical trial and laboratory documentation.
• Experience in maintenance of clinical and laboratory research documents including confidential information for large-scale projects using protected information.
• Experience in analysis of protected health information, public health surveillance data, data collection and subsequent summary reports.
• Experience in and knowledge of Banner, Chrome River, LoboMart, Budget Management, purchasing and payment processes in order to oversee administrative positions in the Center.
• Experience working specifically in the field of clinical and laboratory HPV research.
• Experience in Clinical trial and Clinical research planning, implementation and execution of clinical trials including budget management, risk assessment and regulatory compliance.
• National certification from Association of Clinical Research Professional demonstrating knowledge and high-level experience in clinical research as a Certified Clinical Research Coordinator (CCRC), and / or Certified Clinical Research Professional (CCRP), and / or Certified Clinical Project Manager (CCPM).

Responsibilities

Oversee Phase III clinical trials and manage clinical and laboratory research operations. Coordinate investigator-initiated protocols, informed consents, source documents, and tracking systems. Provide investigator and staff training. Lead large volume projects delivering high quality data to external funding agencies. Maintain quality control, QA and audit-ready documentation in laboratory and clinical research. Analyze protected health information, public health surveillance data, data collection and report. Manage administrative processes including Banner, Chrome River, LoboMart, budget management, purchasing and payment processes. Focus on HPV research and clinical trial planning, implementation and execution including budget management, risk assessment and regulatory compliance.

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.

Salary

$5,844.80 - $10,887.07

Location

Health Sciences Center (HSC) - Albuquerque, NM, Center for HPV Prevention (099A0).

Equal Opportunity

The University of New Mexico is 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.