Clinical Studies Coordinator II - Translational Neuroscience

Job Summary

Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies. Participate in the implementation of multiple NIH-funded clinical research studies that investigate how substance use affects people who have or are at risk for HIV in North Carolina.

Responsibilities

• Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision.
• Plays an active role in recruitment of patients to study.
• Performs protocol specific duties required per the research protocol.
• Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
• Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol.
• Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents.
• Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
• Provides staff relief as required to meet the needs of the department.
• Participates in scheduled team/department meetings.
• Participates in quality improvement projects on an on-going basis.
• May mentor new and less experienced staff.

Essential Functions

• Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision.
• Plays an active role in recruitment of patients to study.
• Performs protocol specific duties required per the research protocol.
• Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
• Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol.
• Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents.
• Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
• Provides staff relief as required to meet the needs of the department.
• Participates in scheduled team/department meetings.
• Participates in quality improvement projects on an on-going basis.
• May mentor new and less experienced staff.

Skills/Qualifications

• Excellent interpersonal, oral, and written communication skills
• Strong organizational skills
• EPIC/WakeOne proficiency to include appropriate documentation of research notes
• Proficient in the use of OnCore/WISER Clinical Trial Management System
• Basic Computer skills
• Fosters/promotes a positive image and professional appearance
• Sensitivity to intercultural relations
• Sensitivity to the maintenance of confidentiality
• Knowledge of Microsoft Products