Clinical Research Mgr - req# 30699 - University of New Mexico

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.

• NM Licensure as a Registered Nurse may be required, as appropriate to the individual position
• Successful candidate must submit to post-offer, pre-employment physical examination and medical history check.
• May be required to submit to annual TB and rubella screening.
• UNM will provide Hepatitis vaccination, candidate may decline vaccination through declination form or may provide record of vaccination from previous employer.

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.

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

Only applications submitted throughthe official UNMJobs site will be accepted. If you are viewing this jobadvertisement on a 3rd party site, pleasevisit UNMJobs to submit an application.

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.