14324 - Clinical Research Specialist
| This position will Assist in the conduct and implementation of traumatic brain injury (TBI) clinical research within the Department of Psychiatry and Center for Neuroimaging. Participate in the initiation, monitoring, completion, and reporting of routine to moderately complex clinical studies in human brain imaging in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP). Organize and implement data review and analysis, assist with protocol development, perform literature review, create and manage regulatory documents, work with multiple investigators, including faculty of both clinical and basic science research studies and provide coordination when new clinical research studies are developed and implemented. Duties and responsibilities: • Manage, process, and perform data entry and quality assurance reviews for cognitive and neuroimaging data from multiple TBI projects and data sets. This includes assistance in the organization and management of archival neuroimaging data, scoring and review of neuropsychological assessment and Magnetic Resonance Imaging (MRI) task behavioral data, quality review of neuroimaging data, and entry of data into study databases. Assist in data analysis and data summaries as directed by PI and other research staff. • Assist with protocol development, preparation of scientific reports, literature reviews and summaries, preparation of data tables and figures, and other written contributions as appropriate. • Create and manage regulatory documentation and oversee regulatory processes for new and ongoing studies, including protocol submission and compliance monitoring for relevant regulatory bodies, creating and updating forms as needed (e.g., IRB, IACUC, FDA, etc.). • Coordinate scientific and investigator meetings, schedule study related appointments. For clinical research studies: identify research subjects based on protocol inclusion/exclusion criteria. Recruit subjects according to IRB/protocol approved methodologies. Consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study. Coordinate subject visits with support services. • Manage administrative functions related to TBI consortium committees. The successful candidate will have data entry and strong math and computer skills, ability to approach information analytically and implement the scientific method to test study hypotheses, be able to multi-task, and be excellent in attention to detail. Must work well as part of a team and independently, and communicate efficiently verbally and in writing. |
Required: Bachelor’s degree from an accredited institution in Science or health-related field with at least 1 year health-related or research experience; or any Bachelor’s degree/Associate’s degree in Allied Health professions with 3 years health-related or research experience or 2 years’ experience in clinical research; or Associate’s degree from an accredited institution in Nursing plus 3 years health-related experience; or LPN/diploma in Nursing with at least 4 years health-related experience. Or individuals can have a Bachelor’s degree from an accredited institution in Nursing or a Master’s degree in Science or health related field with no experience required; or Master’s degree in other fields plus 2 years health-related experience or 1 year experience in clinical research. Appropriate licensure required. Clinical Research Certification desired.
Preferred: Bachelor’s Degree in Psychology, Neuroscience or a biological science-related field from an accredited institution and experience in cognitive and imaging data quality control.
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