Job Description:

• Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.

• Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.

• Collects, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques.

• Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.

• Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.

• Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.

• Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.

• Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.

• Accountable for all tasks in moderately complex clinical studies.

• 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.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.

• Performs other related work as needed.

Preferred Qualifications

Education:

• Bachelor's Degree in a related field.

Preferred Competencies

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

• Strong organizational and communication skills.

• Strong data management skills and attention to detail.

• Ability to read and understand complex documents (e.g., clinical trials).

• Ability to handle competing demands with diplomacy and enthusiasm.

• Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.

• Knowledge of medical terminology.

• Understanding of the IRB submission and review process and when and how to apply for IRB review.

• Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation.

Application Documents

• Resume (required)

• Cover Letter (required)

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.

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About University of Chicago (UC)

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