Clinical Research Coordinator 3

About The Job

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
  • Serves as primary contact for the collection and completion of required study 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
  • Serves as subject matter experts in key CTO processes
  • Manages additional workload during staff changes

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
• 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

Preferred Qualifications

• Clinical Research Coordinator certification or equivalent
• 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
• Oncology experience in a clinical or research setting

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.

Pay And Benefits

Pay Range: $65,000 - $77,000; depending on education/qualifications/experience
Time Appointment: 100% Appointment
Position Type: Civil-Service & Non-Faculty
Labor Represented Staff

About University Of Minnesota

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.

Employment Requirements

Any offer of employment is contingent upon the successful completion of a background check.