Clinical Research Coordinator

About the Job

The Clinical Research Coordinator I 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 toensure consistent and accurate implementation of the protocol. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organizational 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.

• 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 developing case report forms, responding to queries, and meeting data lock deadlines

• In collaboration with the Principal Investigator, 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
• 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, including sharing information up, down, and laterally
• Troubleshoots problems in the development and implementation of protocol procedures
• Coordinates with Investigational Drug Services (IDS), Bio Net, clinical staff, and other departments across campus to deliver drug, collect biospecimens, and execute the study visits according to protocol

All required qualifications must be documented on application materials.

• 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

• 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

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 ourcatchment area.

We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students whoseek exceptional, compassionate precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education.

Pay Range: $41,0…