Clinical Research Coord II

About the Job

OVERVIEW

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.

KEY 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

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 understanding of 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 experiences 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.

Benefits

Working at the University

At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.

The University also 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

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

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 may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

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: http://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 the U of M

The University of Minnesota, Twin Cities (UMTC)

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 the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).