Mgr,Clinical Trials Operations

The Clinical Trials Operations Manager position plays a key role in a multi-project, large state-wide program to assess the population impact of real-world cervical cancer prevention including screening interfaces to HPV diagnostics and vaccination in New Mexico. This position plans, manages and provides leadership for clinical trial and laboratory research and registry operation of The Center for HPV Prevention, housing the New Mexico Pap Registry (NMHPVP), ensuring compliance with all state, federal and sponsor requirements, legislation, guidelines and policies governing the conduct of human subject research and public health reporting. The Clinical Trials Operations Manager collaborates and coordinates efforts across the overall Center for HPV Prevention which includes the management and collaboration of administrators, clinical researchers, laboratory staff, diagnostic laboratories, off-site medical clinics, multiple industry sponsors, national government agencies and internal and external review boards, ensuring compliance with all applicable requirements and guidelines. Additionally, the position provides oversight and guidance of laboratory and clinical research teams ensuring research studies are completed on time, within budget and in compliance with regulations and quality standards. The Clinical Trials Operations Manager will oversee the day-to-day operations of the laboratory and clinical research site, managing all aspects from planning and execution to final analysis and reporting to the Principal Investigator to ensure success, patient safety and regulatory compliance. Key responsibilities include developing protocols, managing budgets and timelines, leading and motivating the research team, coordinating with collaborating sites and vendors, ensuring data quality and maintaining compliance with Food and Drug Administration (FDA), International Council for Harmonization and Good Clinical Practice (ICH-GCP) standards and regulatory guidelines.

Duties and Responsibilities:

1. Collaborate with the Center Director/Principal Investigator for NMHPVPR and clinical trials to develop clinical and laboratory research protocols, informed consents and prepare and submit study start-up documentation, develop and implement recruitment, screening, , clinical and enrollment and retention plans for research participants ensuring protocol and regulatory compliance.

2. Develop source documents (SD), standard operating procedures (SOP), project schedules, timelines, study training material, study reports, monitoring plans in collaboration with internal and external cross-functional teams.

3. Direct and coordinate the collection of clinical research data ensuring attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available data collection in order to maintain high standards of data integrity.

4. Ensure all research participant data and other clinical trial data is securely managed in line with HIPAA regulations, maintaining privacy and confidentiality throughout the research process.

5. Verify and provide quality control review of all research data including source documents, case report forms, medical records, histopathology reports ensuring compliance with study protocols, ICH, GCP and SOPs.

6. Identify protocol deviations, properly documenting and submitting to the Principal Investigator, Sponsor and IRB. Implement retraining and corrective action plans (CAP) to resolve issues of non-compliance or underperformance by addressing root cause and implementing specific, measurable steps with deadlines to prevent recurrence.

7. Oversee a variety of high-level administrative duties such as purchasing database management, expense reimbursement, procurement processes in support of Center's staff and programs ensuring compliance with university, state and federal policies and regulations.

8. Oversee the supervision of laboratory and clinical trial research staff which includes training, distribution of duties, enforcement of internal procedures, problem resolution, motivate employees to achieve peak productivity and performance.

9. Design and implement specific performance metrics in order to provide measurable, objective data to track progress toward goals, improve decision-making, identify areas for improvement and hold individuals and teams accountable with the ultimate goal of increasing efficiency, productivity and give staff a clear and measurable perceptive on their contributions to the program.

10. Complete staff performance reviews in collaboration with Center/NMHPVPR Director.

11. Develop, test, review and implement comprehensive NMHPVPR and clinical trial study logs and reports to track all aspects of laboratory and clinical research projects.

12. Develop, implement and track NMHPVPR and clinical trial policies and procedures, compliance records, required inspections to ensure adherence to safe operation of the laboratory and clinical sites.

13. Participation, implementation and maintenance of short-and long-range planning, identifying areas of excellence and areas requiring improvement to accomplish the Center goals.

14. Data Management for studies evaluating cervical screening, diagnosis and treatment practices captured by the NMHPVPR across the state of New Mexico including directing and coordinating the collection of cervical and other gynecologic data in a group of laboratory-based projects within the Center for HPV Prevention ensuring process compliance with Sponsor and Regulatory requirements and policies

15. Perform miscellaneous job-related duties as assigned.

Expertise in:

1. Clinical and laboratory research operations oversight, including investigator and staff training in compliance with all FDA, IRB, ICH-GCP regulations.

2. Population-based registries or large-scale clinical data management, preferably in HPV, cancer prevention or women's health.

3. Demonstrated knowledge in HPV, cervical cancer and vaccination programs, including public health prevention strategies.

4. 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.

5. Coordinating the execution of large volume projects with a team of laboratory and clinical researchers delivering high quality data to external funding agencies.

6. 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.

7. Maintenance of all clinical and laboratory research documents including confidential information for large-scale projects using protected information.

8. Analysis of protected health information, public health surveillance data, data collection and subsequent summary reports.

9. Working knowledge of Banner, Chrome River, LoboMart, Budget Management, purchasing and payment processes in order to oversee administrative positions in the Center.

10. Work specifically in the field of clinical and laboratory HPV research.

11. Clinical research and clinical trial planning, implementation and execution of clinical trials including budget management, risk assessment and regulatory compliance.

12. National certification from Association of Clinical Research Professional demonstrating knowledge and high-level experience in clinical research as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), and or Certified Clinical Project Manager (CCPM)

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

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.

1. Experience in clinical and laboratory research operations oversight, including investigator and staff training in compliance with all FDA, IRB, ICH-GCP regulations.

2. Experience in Population-based registries or large-scale clinical data management, preferably in HPV, cancer prevention or women's health.

3. Experience in demonstrated knowledge in HPV, cervical cancer and vaccination programs, including public health prevention strategies.

4. 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.

5. Experience coordinating the execution of large volume projects with a team of laboratory and clinical researchers delivering high quality data to external funding agencies.

6. 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.

7. Experience in maintenance of clinical and laboratory research documents including confidential information for large-scale projects using protected information.

8. Experience in analysis of protected health information, public health surveillance data, data collection and subsequent summary reports.

9. Experience in and knowledge of Banner, Chrome River, LoboMart, Budget Management, purchasing and payment processes in order to oversee administrative positions in the Center.

10. Experience working specifically in the field of clinical and laboratory HPV research.

11. Experience in Clinical trial and Clinical research planning, implementation and execution of clinical trials including budget management, risk assessment and regulatory compliance

12. 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)

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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.