at University of Chicago in Chicago, Illinois, United States
Job Description
DepartmentBSD CCC - Network Oncology Research
About the Department
The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 190 faculty members from twenty departments with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.
UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.
Job Summary
This is a project-based role that is expected to last for a duration of18 months.
The Clinical Research Coordinator 1 (CRC1) (Project -Based, 18 month) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC1 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC1 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.
This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.
The job performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.
Responsibilities
- 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, process, ship and store 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.
- 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.
- May prepare and maintain protocol submissions and revisions.
- May assist in the training of new or backup coordinators.
- Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
- Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
- Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
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Work Experience:
Minimum requirements include knowledge and skills developed through ---
Certifications:
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Preferred Qualifications
Education:
- Bachelor's degree.
Experience:
- Two years of clinical research experience or relevant experience strongly preferred.
- Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification strongly preferred.
Preferred Competencies
- Strong organizational skills.
- Strong communication skills (verbal and written).
- Ability to communicate with tact and diplomacy.
- Ability to handle sensitive matters with tact and discretion.
- Excellent interpersonal skills.
- Strong data management skills and attention to detail.
- Ability to participate in protocol review and clinical trials evaluations. Knowledge of medical terminology/environment.
- Ability to handle competing demands with diplomacy and enthusiasm. Excellent time management and ability to prioritize work assignments.
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
- Familiarity with Good Clinical Practices (GCP).
- Ability to read and understand clinical trials protocols.
Working Conditions
- Ability to bend, crouch, or stoop.
- Ability to lift loads up tp 49lbs.
Application Documents
- Resume (required)
- Cover letter (preferred)
When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Research
Role Impact
Individual Contributor
FLSA Status
Exempt
Pay Frequency
Monthly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
Yes
Health Screen Required
Yes
Motor Vehicle Record Inquiry Required
No
Posting Statement
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.
Staff 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.
We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
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.
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