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The primary role of this position include managing the CDC National Spina Bifida Patient Registry and the internal RedCap-based spina bifida patient database. In addition, the coordinator will work with Spina Bifida staff to organize research projects.

The Clinical Research Specialist II will be responsible for:

• Assisting Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Coordinating preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. Corresponding with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
• Recruiting study participants for enrollment in clinical trials. Following individual study protocols. Completing informed consent procedures as assigned. Organizing strategies for recruiting study participants, screening study participants for eligibility on the telephone, in the clinic and other settings as required.
• Organizing study procedures and scheduling study participants for study visits. Assisting the PI during patient visits. Performing study procedures designated for the Study Coordinator.
• Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Completing data entry as warranted.
• Complying with all institutional policies and government regulations pertaining to human subjects protections. Maintaining regulatory binders, case report forms, source documents, and other study documents. Monitoring the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Committee on Clinical Investigations (IRB). Updating protocol and amendment changes.

• Bachelor's degree and a minimum of 5 years of relevant experience OR Masters of Science and 2 yrs relevant work experience.
• The proven ability to work independently.
• The analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data to solve problems.
• Communication skills to effectively deal with conflicting views or issues and mediate fair solutions, and well-developed writing skills. Requires effective communication skills with parents/study participants to explain the research protocol, obtain informed consent, obtain accurate information from them, and provide them with accurate information.