Clinical Research Mgr

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.
Convey 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.
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.
Document
including maintenance of records on medications dispensation and inventory
usage during the course of a study.
Ensures 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.
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.
Responsible for
PCI invoicing and assisting the Clinical Research Operations manager with PCI
Module monthly utilization and quality control for dissemination for reporting
purposes.
Acts as backup to
the CTSC Regulatory Specialist
Performs
miscellaneous job-related duties as assigned.

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 through
the official UNMJobs site will be accepted. If you are viewing this job
advertisement on a 3rd party site, please
visit 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.