Clinical Research Coordinator 1

University of Minnesota; Minneapolis (MN); On-site; USD 41,000 - 55,000; Full time

Job summary

The Clinical Research Coordinator I at University of Minnesota supports data collection, study documentation, and protocol procedures under GCP guidelines. You will work with the PI and study team to ensure accurate implementation and compliance, including IRB, FDA, CFR, and ICH standards.

Key duties include data abstraction, study document maintenance, and coordination of visits with sponsors and monitors to ensure timely, audit-ready records across campus.

Qualifications

• BA/BS degree or combination of education and health-care related 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.

Responsibilities

• 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 source documentation.
• Manages electronic data capture systems, including CRF development, queries, and data lock deadlines.
• Collaborates with PI to interpret protocols and create source documents.

Skills

Attention to detail

Organizational skills

Independent work

Microsoft Office

Education

BA/BS degree or equivalent

Tools

Epic/Oncore

Job description

About the Job

The Clinical Research Coordinator I is responsible for providingtechnical expertise and overall management of clinical researchdata collection, study documentation, protocol-required procedure execution, and collaboration with PI and study team toensure consistent and accurate implementation of the protocol. Theincumbent will be expected to follow Good Clinical Practice (GCP) and all organizational policies and procedures forpatient safety and data integrity, including but not limited to theInstitutional Review Board (IRB), Food & Drug Administration(FDA), Code of Federal Regulations (CFR), and InternationalConference on Harmonization (ICH) guidelines.

SPECIFIC 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 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

Study Coordination (30%)

• 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), BioNet, clinical staff, and other departments across campus to deliver drug, collect biospecimens, and execute the 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 certificationExperience 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 patientcare 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 and Benefits

Pay Range: $41,000 - $55,000; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type : Civil-Service & Non-Faculty LaborRepresented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

• 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

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.

Diversity

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: diversity.umn.edu

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.

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.

At the University of Minnesota, we are proud to be recognized by Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023, 2025, 2026), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence &Industry Awards recognition for employee appreciation and work-life flexibility.