Student Veterans of America Jobs

Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

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The University of Chicago Regulatory Affairs Manager 1 - JR26894-3800 in Chicago, Illinois

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/11998493 Department

BSD CCC - CCT Pod2

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 at-will position is wholly or partially funded by extramural funds (e.g., grant, gift, endowment) which is renewed under provisions set by the grantor. This employment will be contingent upon the continued receipt of these extramural funds and satisfactory job performance. If this position is eliminated due to the discontinuation of extramural funding, a minimum of one pay period written notice will be given. If exempt: 30 days, If non-exempt: 2 weeks, or pay in-lieu of notice.

This position 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.

Responsibilities

  • Prepares and submits new study applications, amendments, and continuing reviews, to the IRB and other applicable internal review committees.
  • Creates and maintains site regulatory files for each assigned study.
  • Communicates updates and changes, e.g. protocol amendments, to the clinical research team and sponsor/funding agencies.
  • Participates in internal clinical research audit program as assigned.
  • Multi-site regulatory coordination as assigned. Acts as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments, review of site consent forms, collection of site specific essential documents (IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.), and maintenance of up-to-date regulatory files for external participating sites.
  • Prepares and collects all necessary documents to activate protocols, e.g. consent forms, Form FDA 1572, etc.
  • Prepares protocol updates, coordinates weekly program meetings, distributes relevant updates to participating sites as applicable.
  • Coordinates department or clinic compliance with a moderate level of guidance.
  • Plans and executes internal and external audits and activities to support regulatory agency inspections.
  • Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
  • 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 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

  • Completion of a certificate or degree program in clinical trial management /regulatory affairs or directly related field.

Experience:

  • Clinical research or directly related experience.
  • Prior clinical trial regulatory experience.

Technical Skills or Knowledge:

  • Solid understanding of regulations covering clinical trials/human subjects research.
  • Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
  • Familiarity with clinical trial management systems and/or databases.

Preferred Competencies

Excellent written and interpersonal skills.

Effectively present oral and written information.

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