Clinical Research Coordinator

5 days ago

Chicago, Illinois, United States Rush University Full time
Job Summary:

The Clinical Research Coordinator will support the Office of Research Affairs' Clinical Research Administration Division, their clinical department / division, and in partnership with the Principal Investigator (PI), Co-Investigator(s), other study personnel, and sponsoring agents to ensure protocols are conducted in accordance with the principles of Good Clinical Practice (GCP).

The ideal candidate will have a strong understanding of clinical research principles, including Good Clinical Practices and Good Documentation Practices. They will be responsible for coordinating and managing multiple and/or complex clinical research studies, including grant-funded, industry-sponsored, and investigator-initiated clinical research studies.

The Clinical Research Coordinator will independently coordinate the implementation and execution of study protocols and perform a variety of study-related duties. They will also be responsible for ensuring procedural documentation is accurate, complete, and in compliance with institutional, local, state and federal guidelines and regulations related to clinical research.

Responsibilities:

• Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking and provides study updates to study participants throughout the conduct of the study.
• May collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
• Submits or partners with a regulatory coordinator to submit study-related documents, study protocols and study protocol amendments to the IRB per policy and procedure.
• Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state and federal guidelines and regulations related to clinical research.
• May collect, process and ship potentially biohazardous specimens.
• May administer more complex structured tests and questionnaires according to research study protocols. May utilize study-related technology and equipment as part of assessment procedures.
• Provide ongoing study status updates, responds to questions and may create summary report(s) for distribution to PI, Administrator, Office of Research Affairs, Sponsor and Compliance throughout the conduct of the study.
• Organize and participate in auditing and monitoring visits.
• Report unanticipated problems (protocol deviations, adverse events, and serious adverse events).
• Partner with PI(s), sponsor, compliance, clinical staff and manager to identify and improve more complex processes as it relates to the conduct of the research study.
• May provide oversight, training and coaching to less experienced staff.

Requirements:

• Bachelor's degree and 4 years of clinical research experience OR 8 years of clinical research experience.
• 3 years coordinating Human Subjects research.
• Demonstrate advanced knowledge of Good Clinical Practices and Good Documentation Practices.
• Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.
• Strong project management skills including ability to meet deadlines and help coordinate multiple aspects of the ongoing project.
• Demonstrated problem-solving, critical decision makings and professional judgement.
• Strong analytical and organizational skills with a high attention to details.
• Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants and vendors.
• Strong verbal and written communication with ability to communicate complex concepts to multiple audiences.
• Demonstrated ability to collaborate within multi-disciplinary team settings.
• Availability to work evenings, overnight and weekends if called for under the study protocols.
• Travel may be required.

Rush University is an Equal Opportunity Employer:

Rush University is committed to creating a diverse and inclusive environment. We are an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

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