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.