Clinical Research Supervisor

The Department of Medicine, Division of Cardiology has developed a clinical research infrastructure within the Division.  The goals are to increase industry-sponsored research, create a system that will assist a physician within the division to operationalize an investigator-initiated study, and to develop a general cardiology cohort study.  The purpose of this position is to carry out the needed tasks as a part of ongoing and future clinical and translational research projects in the Division of Cardiology.

The CCRU Infrastructure Supervisor reports to the Cardiology Clinical Research Infrastructure Manager. Under their direction, the Infrastructure Supervisor is responsible for assisting with hiring, supervising, and leading a team of 15-20 clinical research coordinators and potentially 2-3 senior clinical research coordinators. The Supervisor is responsible for assessing workload assignments, direct oversight of data collection and reporting, and clinical trial management to accomplish implementation of protocols within the program that meet federal, state, and institutional policies and guidelines. The Supervisor acts as an advisor to ensure that proper training competencies have been accomplished and that overall workload can be managed safely and accurately. The Supervisor advises the Clinical Research Infrastructure Manager of all resource allocation and data management issues. This includes working closely with the department’s financial team to ensure adequate study funds are allocated and payments from study sponsors are reconciled.

Required Qualifications :

• Bachelor’s degree in a science field, and 2 years related experience in a research setting, either in a laboratory or clinical setting, or equivalent combination of education and relevant experience
• Clinical Trial Professional certification from a professional society within one year in position
• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals
• In-depth knowledge of clinical trials, protocols, FDA regulations, and complex visit structures
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal, and written communication skills
• Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
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• Demonstrated ability to interpret and apply policies and regulations
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities
• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills