Clinical Research Mgr

The Department of
Internal Medicine Clinical Trials Unit (CTU) at UNM seeks a Clinical
Research Manager for regulatory compliance. This position will work
closely with the Manager of Clinical Research Operations, Research Nurses,
Research Coordinators, CTU Medical Directors and Internal Medicine Principal
investigators in developing guidelines for clinical research trials, and
ensuring documentary compliance to federal, local, and University
policies. This position requires a firm understanding of
good clinical and community practices in conducting research, in accordance
with established study protocols and in accordance with federal, local, and
institutional policies and guidelines for clinical trials. Additionally,
the position requires experience with the process of the application, start up,
and maintenance of NIH funded clinical trials and will need strong
interpersonal and communication skills, and the ability to work effectively
with a variety of university departments, health care providers, funding
agencies, university researchers and collaborating private industries.

Duties and Responsibilities

• Provide technical support, review materials for submission, develop processes and guidelines for research projects.
• Maintain HuronIRB and Third party Central IRBs, including initial submissions, continuing reviews, all modifications that can include updating study documents, study team list, RNIs, etc. for all studies supported by the CTU.
• Provide advice and guidance to research investigators and personnel with regards to preparation and submission of new studies including the creation of site level consent forms, local protocols, and other documentation necessary to ensure compliance with human subject protections in biomedical and clinical research.
• Collaborate with Principal Investigators (PIs) to assist with questions and concerns regarding research which include the creation and review of consent forms, protocols and other compliance items with human subject protections in biomedical and clinical research.
• Act as a point of contact for up-to-date understanding of Federal, State, and University laws, regulations, and guidelines for research studies.

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.

Preferred Qualifications:

• Two or more years of experience in coordinating the implementation and execution of study drug study/clinical trials, specifically in the Huron system
• Track record of contributions to the development and implementation of study protocols, informed consent documents, procedures and techniques
• Knowledge of federal regulations, guidelines and industry standards for the coordination of human research
• Excellent communication skills to interact regularly with faculty and clinical staff regarding the individual project(s) and provide reporting as required
• Ability to complete start up initiatives as required by the individual project(s)
• Experience drafting and managing IRB submissions
• Ability to provide technical oversight and instruction to research assistants, clinical research nurses, technicians and other research staff

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.