Clinical Research Mgr

at  University of New Mexico

POSITION SUMMARY

The University of New Mexico Health Sciences Center (UNMHSC) Clinical and Translational Science Center (CTSC) is seeking a dynamic, detail-oriented, results-driven individual to join our team as a Clinical Research Program Manager to oversee the daily operations and research staff of the Participant and Clinical Interactions (PCI) unit.
The Clinical Research Program Manager will oversee the management of the clinical trials to provide an environment that ensures the conduct of research according to Good Clinical Practice. The manager is also responsible for providing necessary training of the staff and clinical investigators to enhance the performance of clinical research at UNM. The manager will manage collaborative research projects; assist in development of research concepts and protocols, provide guidance, manage, and oversee the work of the research staff, assist with developing and administering program budgets and funding, and help to oversee the day-to-day administration of the clinical research unit.

Duties and Responsibilities:

• Supervision of PCI clinical research personnel, which includes recruiting, hiring, training and managing clinical research staff (coordinators and nurses). Evaluation and management of staffing coverage for clinical activities. Conveying roles and responsibilities, procedures and duties to research staff to ensure uninterrupted workflow. Provides adequate care and treatment of research subjects. Ensures that all clinical activities are carried out in accordance with established research protocols, and with acceptable clinical procedure and safety standards. (40%)
• Participates in and coordinates the planning, development, and implementation of clinical protocols in accordance with research parameters set out by the principal investigator. This includes administrative and logistical procedures, programs for the recruitment, screening, enrollment and retention of clinical research subjects and /or volunteers. Documentation including maintenance of records on medications dispensation and inventory usage during the course of a study. Ensures the confidentiality of subject records, monitors and records patient response to treatment. Communicates study data and results to investigators. Maintains complete and accurate source documentation. Oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies, as appropriate. (25%)
• Provides consultation, liaison, and administrative facilitation between investigators and ancillary departments, research subjects, sponsoring organizations, and/or regulating bodies. Identifies and addresses problems, facilitates audits, and corrects deficiencies. (20%)
• Responsible for PCI invoicing and assisting the Clinical Research Operations manager with PCI Module monthly utilization and quality control for dissemination for reporting purposes. (5%)
• Acts as backup to the CTSC Regulatory Specialist (5%)
• Performs miscellaneous job-related duties as assigned. (5%)

TERM APPOINTMENT; FUNDING AVAILABLE THROUGH 05/31/2025; CONTINUANCE BEYOND THAT DATE SUBJECT TO AVAILABILITY OF ADDITIONAL FUNDING. The UNM Clinical Research Center (CTSC) has over 35 years of continuous funding as a well-established NIH FUNDED research center.
See the Position Description for additional information.

MINIMUM QUALIFICATIONS

Bachelor’s degree; at least 3 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.

PREFERRED QUALIFICATIONS

Experience in: (Must be detailed in your resume)

• Nursing, Research Coordinator, clinical research experience
• Experience supervising and training staff
• Effective in managing multiple clinical research studies
• Ability to effectively adapt to changing priorities
• Ability to effectively and efficiently manage clinical research day to day operations
• Working knowledge and experience with Central IRB and Local IRB submissions
• Developing and maintaining record keeping systems and procedures.
• Knowledge of federal guidelines and industry standards for the coordination of human research
• Knowledge of laws, regulations, methods and techniques in the areas of clinical research.
• Skill in re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures

• Supervision of PCI clinical research personnel, which includes recruiting, hiring, training and managing clinical research staff (coordinators and nurses). Evaluation and management of staffing coverage for clinical activities. Conveying roles and responsibilities, procedures and duties to research staff to ensure uninterrupted workflow. Provides adequate care and treatment of research subjects. Ensures that all clinical activities are carried out in accordance with established research protocols, and with acceptable clinical procedure and safety standards. (40%)
• Participates in and coordinates the planning, development, and implementation of clinical protocols in accordance with research parameters set out by the principal investigator. This includes administrative and logistical procedures, programs for the recruitment, screening, enrollment and retention of clinical research subjects and /or volunteers. Documentation including maintenance of records on medications dispensation and inventory usage during the course of a study. Ensures the confidentiality of subject records, monitors and records patient response to treatment. Communicates study data and results to investigators. Maintains complete and accurate source documentation. Oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies, as appropriate. (25%)
• Provides consultation, liaison, and administrative facilitation between investigators and ancillary departments, research subjects, sponsoring organizations, and/or regulating bodies. Identifies and addresses problems, facilitates audits, and corrects deficiencies. (20%)
• Responsible for PCI invoicing and assisting the Clinical Research Operations manager with PCI Module monthly utilization and quality control for dissemination for reporting purposes. (5%)
• Acts as backup to the CTSC Regulatory Specialist (5%)
• Performs miscellaneous job-related duties as assigned. (5%