Clinical Research Spec I

Responsibilities

• Coordinates the activities associated with human subject research.
• Assumes responsibility for the least complex clinical research protocols and timelines.
• Performs structured work assignments.
• Captures and documents adverse events per protocol.
• Collects and enters data.
• Observes for deviations and takes corrective actions.
• Reports deviations when they occur.
• Maintains study continuity and coordinates study participants and research procedures.
• Ensures protocol compliance and coordinates logistics, research procedures, and study participants.
• Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Performs data collection and data entry activities according to protocol requirements and established operational procedures and timelines.
• Observes for deviations and takes action to minimize them.
• Maintains all logs, including OnCore system entry and research tabs in the Electronic Medical Record (EMR).
• Enters research data into data collection forms and/or study databases.
• Complies with Good Clinical Practice and the Code of Federal Regulations.
• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
• Continuously learns about industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Maintains CITI and Conflict of Interest (COI) certification and renewal as required.
• Gains knowledge in medical research terminology.
• Continuously gains proficiency in UR-specific research software needed to manage clinical research protocols.
• Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards.

Requirements

• Bachelor's degree required
• Or equivalent combination of education and experience

Qualifications

• Understands and follows simple research protocols and procedures preferred
• Fully adheres to applicable safety and/or infection control standards preferred
• Understands and follows data integrity standards and processes preferred
• Strong interpersonal, communication, and organizational skills preferred
• Highly collaborative, works well in teams preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred