University of Chicago
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 150 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.
About the Department
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.
The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.
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.
Responsible for study start up activities and regulatory maintenance of assigned portfolio of clinical research studies.
Creation and maintenance of study regulatory files in study binders, shared drives, and/or eRegulatory product.
Prepares regulatory files for monitoring and auditing activities and addresses outstanding issues resulting from routine monitoring activities.
Provides guidance to PIs, research team, auditors, and other affiliated staff related to the maintenance of regulatory compliance.
Participates in working groups and/or other internal committees as assigned.
Completes internal trainings as required.
Coordinates department or clinic compliance with a moderate level of guidance.
Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
Performs other related work as needed.
Education:Minimum requirements include a college or university degree in related field.
4+ years of prior work experience in clinical research regulatory compliance.
Advanced degree or certification in clinical research or related field.
Clinical research certification (SOCRA, ACRP, etc.).
Demonstrated familiarity with federal and international regulations governing the oversight and conduct of clinical research.
Strong oral and written communication skills with both teams, faculty, and external vendors and sponsors.
Project management experience.
Performs assigned tasks independently.
Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures as well as other regulatory policies regarding human subject research.
Completion of human subjects and Good Clinical Practice trainings within 30 days of hire and maintaining compliance with training requirements (refresher training every 3 years).
Completion of clinical research certification (SOCRA, ACRP, etc.) within 2 years of hire (must maintain certification).
Hybrid work arrangements will be considered.
Cover letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Legal & Regulatory Affairs
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
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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.
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