Bachelors degree in public health, neuroscience, nursing, healthcare or related field. Master's degree preferred.
Minimum of six (6) to eight (8) years in a high volume complex clinical research office with six (6) years of direct experience in project administration and management of multiple multi-center investigator Phase I - IV clinical trials or equivalent required. Highly developed communication skills, proven ability to work with a wide range of professionals. Proficient in medical terminology, physiology and pharmacology. Experience required in navigating clinical research regulations including but not limited to ICH/GCP and CFR regulations. Clinical software expertise with Epic, Citrix, OnCore, Redcap, MS applications, research databases and electronic data capture (EDC) systems required.
Proven leadership and project management skills. Proven ability to manage and monitor policies, practices and procedures of research staff. Well-developed oral and written communication, organizational, analytical and training skills. Comprehensive knowledge of research methodologies including regulatory and GCP policies pertaining to research involving human subjects. Demonstrated knowledge of pharmaceutical drug and FDA device development. Strategic ability to establish, maintain and develop collaborations both internally and externally. Independent decision making, problem solving and negotiation skills. Proficiency in various data management and software programs to support clinical research.