The Department of Ophthalmology & Visual Sciences is looking for one Clinical Research Coordinator.

This position manages and coordinates the timely handling of all components of a new FDA-approved clinical research protocol in the Department of Ophthalmology and Visual Sciences, including pre and post research activities, internal and external to the clinical setting. Responsible for monitoring the conduct of the clinical trial at all investigator sites, which foremost entails ensuring patient safety and data integrity. Coordinates comprehensive patient protocol treatment schedules to maintain compliance to protocol requirements. Develops and implements effective patient recruitment strategies. Oversees and participates in subject recruitment, screening, scheduling, testing, and data management for a multi-faceted investigation. Coordinates clinical trial enrollment activities at domestic and international participating sites.

 Protocol Management

• Assist in establishing and coordinating the implementation of clinical research protocol priorities and organization structure.
• Notify and inform physicians, clinical staff, affiliates and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research program
• Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), Protocol Review Committee, grant sponsors, and regulatory agencies (including FDA).
• Review clinical procedures and evaluations regularly to ensure protocol compliance, including management of the treatment intervention in temperature-controlled storage units.
• Work closely with both Post Award – Accounting and Sponsor regarding patient billing. Communicate with UIC Compliance regarding hospital pricing.
• Assist Post Award with clinical trial close out. Reconcile internal bills, close human subjects program advances, etc.
• Act as liaison between grant investigators, study staff and the UIC IRB office, grant sponsors and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple projects.
• Communicate with external study sites to ensure protocol adherence
• Work with other sites in a multicenter clinical study

Client Enrollment and Protocol Compliance

• Assist physicians and clinical staff in identification, recruitment and enrollment strategies of patients to increase enrollment and to meet clinical research protocols.
• Analyze retention rates and formulates plans to retain participants.
• Execute informed consent process and monitors patient status; Enroll participants into programs, explaining the research protocols to the clients and supporting family/friends, and obtain appropriate consent forms.
• Ensure that participant enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines.
• Participate in conducting surveys of participants and supporting family/friends.
• Collect and review client evaluations/assessments, surveys, and participant interviews to develop reports for the PI and appropriate agencies and grant sponsors. Evaluate data to determine project effectiveness.
• Assist investigators in preparing study data, literature reviews, analysis for meeting presentations and publications.
• Perform other related duties and participate in special projects as assigned.

A minimum of a master’s degree in public health or population health related field required, epidemiology preferred; OR a bachelor degree in nursing, mental health, psychology, pharmaceutical sciences, social science, or a related field, with certification as a Clinical Research Coordinator (CCRC) preferred.

At least one-year experience in a research discipline required. Experience in a clinical research setting, experience working with Federal Regulations and IRB’s required.

Prior experience with medical terminology and procedures including electronic medical records and billing preferred.

Ability to manage multiple tasks. Strong interpersonal and customer service skills. Requires excellent communication, organization, presentation and computer/pc skills.

Proficiency in Microsoft Office and other related software required (e.g., Outlook, Excel, Word and PowerPoint); REDCap and basic statistical software packages strongly preferred (e.g., SAS, STATA).

Knowledge of research protocols, principles and procedures; knowledge of aspects of clinical trials such as screening, interviewing, case reports forms; knowledge of experimental design, mathematics, statistics, computer applications and computer data management; oral and written communication skills; knowledge of a science such as biology or psychology; ability to identify, produce, organize, evaluate and interpret data; knowledge of ethics and regulatory procedures (i.e. informed consent, IRB applications, data safety and monitoring plans) involved with clinical trials and other clinical research; ability to work as a member of a project team; knowledge of clinical tasks required for research (e.g. phlebotomy, centrifugation, interviewing).