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Clinical Research Coordinator III

Company: University of Minnesota
Location: Saint Paul
Posted on: January 26, 2023

Job Description:

Apply for JobJob ID352094
LocationTwin Cities
Job FamilyResearch-Support
Full/Part TimeFull-Time
Regular/TemporaryRegular
Job Code8352P3
Employee ClassCivil Service
Add to Favorite JobsEmail this JobAbout the Job


JOB SUMMARY
The Clinical Research Coordinator III is responsible for providing technical expertise and overall management of clinical research data collection, study documentation, protocol-required procedure execution, and collaboration with PI and study team to ensure consistent and accurate implementation of the protocol. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organization policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.

SPECIFIC RESPONSIBILITIES

Trial Management / Study Coordination (60%)
* Interprets protocols and creates source documents needed for clinical research study
* Identifies and reports protocol deviations within the required timeline in accordance with institutional requirements
* Ensures protocol adherence by communicating and ensuring study parameters are executed according to protocol
* Oversees visits with outside sponsors, including site initiation visits, interim monitoring visits and closeout visits
* Collaborates with PI and study team to enroll study participants, execute study-required procedures, and maintain accurate source documentation
* Maintains a processing and tracking system for protocol-required biospecimens, data, and procedures
* Works as a member of the study team with positive and timely written and verbal communication, including sharing information up, down, and laterally
* Troubleshoots problems in the development and implementation of protocol procedures
* Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, and other bodies across campus to deliver drug, collect biospecimens, and execute the study visits according to protocol

Data Management (25%)
* Serves as primary contact for the collection and completion of required study documentation
* Develops and maintains study documentation to ensure audit-proof compliance
* Abstracts data from medical record to ensure accurate and complete source
documentation
* Manages electronic data capture systems, including but not limited to building the case report forms, responding to queries, and meeting data lock deadlines
* Demonstrates proficiency with Common Terminology Criteria for Adverse Events (CTCAE), medical terminology, critical lab values, and other disease-specific diagnostic
criteria

Lead Activities (15%)
* Mentors and trains new staff, providing task level guidance to CRCs I and II
* Serves as subject matter experts in key CTO processes
* Manages additional workload during staff changes
Qualifications


All required qualifications must be documented on application materialsRequired Qualifications:
* BA/BS with at least 4 years of experiences or an advanced degree and 2 years of experience or 8 years of relevant education & healthcare or research experience
* Oncology experience in a clinical or research setting
* Excellent attention to detail and organizational skills
* Ability to work independently, as part of a team, and with changing priorities
* Computer proficiency in a PC environment including Microsoft Office products
* Ability to sit for extended periods of time
* Clinical Research Coordinator certification or equivalent

Preferred Qualifications:* Experience with disease-specific research or clinical care
* Experience with patient contact / care
* Experience abstracting clinical data and familiarity with medical terminology
* Experience with Epic, Oncore, or equivalent medical record / Clinical Trial Management
Systems
About the Department


The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region. Since the time of the first award in 1997, there has been consistent growth of the membership and research base, enabling our center to further advance our knowledge and enhance care for our catchment area. We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students who seek exceptional, compassionate, precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education.
Benefits


Working at the UniversityAt the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.The University also offers a comprehensive benefits package that includes:

  • Competitive wages, paid holidays, and generous time off
  • Continuous learning opportunities through professional training and degree-seeking programs supported by the
  • Low-cost medical, dental, and pharmacy plans
  • Healthcare and dependent care flexible spending accounts
  • University HSA contributions
  • Disability and employer-paid life insurance
  • Employee wellbeing program
  • Excellent retirement plans with employer contribution
  • Public Service Loan Forgiveness (PSLF)
  • Financial counseling services
  • Employee Assistance Program with eight sessions of counseling at no costPlease visit the for more information regarding benefits.
    How To Apply


    Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-UOHR (8647).
    Diversity


    The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.
    Employment Requirements


    Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

    Please note: All employees at the University of Minnesota are required to comply with the University's Administrative Policy: COVID-19 Vaccination and Safety Protocol by either providing proof of being fully vaccinated on their first day of employment, or complete a request for an exemption for medical exemption or religious reasons. To learn more please visit:
    About the U of M


    The University of Minnesota, Twin Cities (UMTC)The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

Keywords: University of Minnesota, St. Paul , Clinical Research Coordinator III, Healthcare , Saint Paul, Minnesota

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