Clinical Research Coordinator 1

About the role

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

Responsibilities

• Data Management (70%)
  • 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 records to ensure accurate and complete source documentation.
  • Manages electronic data capture systems, including developing case report forms, responding to queries, and meeting data lock deadlines.
• Study Coordination (30%)
  • Interprets protocols and creates source documents needed for clinical research studies in collaboration with the Principal Investigator.
  • Identifies and reports protocol deviations within the required timeline in accordance with institutional requirements.
  • Coordinates visits with sponsors, monitors, and other key collaborators, 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, 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 departments across campus to deliver drug, collect biospecimens, and execute study visits according to protocol.

Qualifications

All required qualifications must be documented on application materials.

• Required Qualifications
  • BA/BS degree, or a combination of education and research or health care work experience to equal at least four years.
  • 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
  • Oncology research experience in an academic setting.
  • Experience abstracting clinical data and familiarity with medical terminology.
  • Clinical Research Coordinator certification.
  • 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 the center to further advance knowledge and enhance care for its catchment area. MCC is 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

Pay Range: $41,000 - $55,000, depending on education, qualifications, and experience.

Benefits

• 100% time appointment (full-time position).
• Comprehensive benefits package, including:
  • Competitive wages, paid holidays, and generous time off.
  • Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program.
  • 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) opportunity.
  • Financial counseling services.
  • Employee Assistance Program with eight sessions of counseling at no cost.
  • Employee Transit Pass with free or reduced rates in the Twin Cities metro area.