Clinical Research Mgr
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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
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.
Benefits
- medical, dental, vision, and life insurance
- educational benefits through the tuition remission and dependent education programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
