Department
BSD MED - Endocrinology - Vokes Research Staff
About the Department
Job Summary
The job provides technical support activities related to documents, analyzes, and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. By performing these duties with limited supervision and/or guidance, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
Responsibilities
Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Recruit and interview potential study patients with guidance from PI and other clinical research staff.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Coordinate 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.
Protect 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.
Understand 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. Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
May prepare and maintain protocol submissions and revisions.
May assist in the training of new or backup coordinators.
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.
Accountable for all tasks in moderately complex clinical studies.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
---
Preferred Qualifications
Education:
Bachelors degree.
Experience:
Clinical research experience or relevant experience.
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)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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: http://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.
Skills Required
- College or university degree in a related field
- 2-5 years of work experience in a related job discipline
- Knowledge of IRB submission and review process and regulatory compliance
- Experience recruiting, obtaining informed consent, and conducting patient assessments
- Ability to collect, process, ship, and store specimens following aseptic techniques
- Maintain accurate research records (informed consent, CRFs, source documentation, drug logs)
- Protect patient confidentiality and handle PHI in compliance with federal regulations
- Drug test and health screening (pre-employment requirements)
- Resume/CV upload required for application
- Cover letter upload required for application
- Clinical research experience or relevant experience
- Ability to follow SOPs, communicate effectively, prioritize, and work independently or in a team
What We Do
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to rigorous inquiry and intellectual freedom draws pathbreaking scholars to our global campuses, where field-defining ideas are born that challenge and change the world. The University of Chicago has its main campus on Chicago's South Side and seven international campuses and centers throughout the world. Students can choose from 53 majors and 47 minors in the undergraduate College, with four divisions and seven professional schools for graduate study.
