Senior Implementation Research Coordinator

University of Chicago - Chicago, IL

Full-time - Mid Level

Chicago, IL

Educational Services

About the position

The Senior Implementation Research Coordinator (SIRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and will directly report to the Director of Research. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the SIRC supports, facilitates and coordinates independently the daily activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the SIRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the study. This position is grant funded.

Responsibilities

• Manages all aspects of conducting research including: protocol development for the following tasks: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• Coordinates the conduct of the study from startup through closeout.
• Educates community members about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
• Performs assessments at visits and monitors for adverse events.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• Protects community members and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), and study related communication.
• Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
• Ensures compliance with federal regulations and institutional policies.
• May prepare and maintain protocol submissions and revisions.
• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
• Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
• Performs other related work as needed.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Nice-to-haves

• Bachelors degree in a related field.
• Clinical or public health research experience.
• Experience coordinating multiple studies (e.g., investigator initiated, multi-site trials).

Benefits

• Benefits Eligible: Yes