Senior Implementation Research Coordinator
University of ChicagoAbout the role
Department
About the Department
Job Summary
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.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.---
Work Experience:
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Certifications:
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Preferred Qualifications
Education:
Bachelors degree in a related field.
Experience:
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