Clinical Research Coord III

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. This position is not eligible for visa sponsorship.

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
  • Covers 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 records 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

• Required 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

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

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.

Affirmative Action Statement

While our salary ranges provide a framework, it is important to note that most of the time, the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization. As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.

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.