Clinical Research Coordinator II

University of Minnesota; Minneapolis (MN); On-site; USD 52,000 - 63,000; Full time

Benefits offered by this job

Competitive wages

Paid holidays

Learning opportunities

Retirement plans

Transit benefit

Employee assistance program

Job summary

University of Minnesota is seeking a Clinical Research Coordinator II to manage data collection, study documentation, and protocol procedures in collaboration with the PI and study team.

The role emphasizes GCP compliance, IRB/FDA/ICH guidelines, and coordination across departments to ensure accurate implementation of the protocol. VISA sponsorship is not available.

Qualifications

• BA/BS with at least 2 years of experience or 6 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.

Responsibilities

• Interpret protocols and create source documents for clinical research.
• Identify and report protocol deviations within required timelines.
• Ensure protocol adherence by communicating study parameters.
• Oversee visits with outside sponsors (site initiation, monitoring, closeout).
• Collaborate with PI and study team to enroll participants and conduct procedures.
• Maintain source documentation and biospecimen/data tracking systems.
• Communicate effectively within the study team.
• Troubleshoot protocol procedures and collaborate with IDS/BioNet/clinical staff.
• Coordinate with IDS, BioNet, and clinical staff to deliver drug and collect biospecimens.

Skills

Attention to detail

Organizational skills

Independent work

Teamwork

Microsoft Office proficiency

Education

BA/BS or equivalent healthcare/research experience

Tools

Microsoft Office

Job description

About the Job

The Clinical Research Coordinator II 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.

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 (40%)

• 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

Qualifications

All required qualifications must be documented on application materials.

REQUIRED QUALIFICATIONS

• BA/BS with at least 2 years of experience or 6 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

• Oncology research experience in an academic setting
• Experience with patient contact / care
• 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 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: $52,000 - $63,000; depending on education/qualifications/experience

Time Appointment: 100%

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

The University 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 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