Job Description

Job Description:

• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

• Recruits and interviews potential study patients with guidance from PI and other clinical research staff.

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

• Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

• Coordinates the conduct of the study from startup through closeout, including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

• Educates patients 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 patients' 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), drug dispensing logs, 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.

• May assist in the training of new or backup coordinators.

• Responsibilities may include the following non-laboratory duties: may assist in recruiting and scheduling research subjects; assisting with developing or amending study protocols; assisting with developing data collection tools; assisting with building databases; and providing general administrative support.

• Responsibilities may include the following laboratory duties: setting up and performing experiments; interacting with students and other laboratory staff under the direction of the principal investigator.

• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.

• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

• Accountable for all tasks in moderately complex clinical studies.

• 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.

Experience:

• Clinical research experience or relevant experience.

• Coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Preferred Competencies

• Aware of safety hazards and take appropriate precautions.

• Communicate in writing.

• Communicate orally.

• Comprehend technical documents.

• Condense complicated issues to simple summaries that can be understood by a variety of constituents.

• Create and deliver presentations.

• Develop and manage interpersonal relationships.

• Exercise absolute discretion regarding confidential matters.

• Follow written and/or verbal instructions.

• Give directions.

• Handle sensitive matters with tact and discretion.

• Handle stressful situations.

• Learn and develop skills.

• Maintain a high level of alertness.

• Pay attention to detail.

• Perform multiple tasks simultaneously.

• Prioritize work and meet deadlines.

• React effectively, quickly, calmly, and rationally during conflicts and emergencies.

• Train or teach others.

• Work effectively and collegially with little supervision or as member of a team.

• Work independently.

Application Documents

• Resume/CV (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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

About University of Chicago (UC)

One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.

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