Rsch Mgr 1-Clin Rsch Prj Mgmt

The Center for Pediatric Obesity Medicine (CPOM), in the Department of Pediatrics seeks a full time Research Coordinator Manager to develop and oversee study coordination activities for a new decentralized, virtual clinical trial of 1,020 adolescent participants with an interventional medication over the course of a 5-year project. This is a full time, in-person position reporting to the CPOM Associate Director and under the supervision of the Principal Investigator.

Position Summary:
The Coordinator Manager is a dedicated supervisory role responsible for the day-to-day management of clinical research operations and the establishment and oversight of the study coordinator team. This position ensures the rigorous execution of the study protocol, maintains high standards of data integrity, and manages the logistical infrastructure of the trial. While primarily a leadership and management role, the Coordinator Manager provides essential back-up support for coordinator duties during high-volume periods or staffing gaps to ensure uninterrupted study flow, including periodic evening coverage.

Key Responsibilities and Duties

Staff Supervision and Performance Management: 45%
* Team Leadership: Supervise the clinical coordinator staff, including direct oversight of daily activities, workload distribution, and resource management.
* Performance Management: Conduct regular performance reviews, monitor staff productivity, and manage work accountability through objective metrics.
* Schedule Coordination: Create and manage the coordinator schedule, including tracking hours and ensuring adequate cross-coverage for all study visits and recruitment activities.
* Training & Onboarding: Lead the onboarding process for new hires and provide ongoing training to ensure the team is proficient in the Manual of Operations (MOP) and institutional policies.
* Fidelity Oversight: Ensure coordinator fidelity to the study protocol and Standard Operating Procedures (SOPs) through regular observation and documentation audits.

Operational Logistics and Problem Resolution: 35%
* Lead the development and optimization of standardized study workflows for virtual study assessments, remote laboratory coordination, study medication dispensing processes, and centralized study participant communication systems.
* Triage and Issue Management: Serve as the primary point of contact to triage and resolve operational issues with key partners, specifically Quest Labs and the Research Pharmacy (IDS).
* Safety Escalation: Act as the first line of escalation for clinical or protocol concerns, routing critical issues to the Medical Safety Officer as necessary.
* Retention Strategy: Lead study participant retention efforts, monitoring follow-up rates and implementing strategies to minimize attrition.
* Supply and Vendor Management: Manage and oversee study-specific logistics, including transportation setup for participants as needed, vendor coordination for study specific supplies, and participant payment distribution
.
Data Management and Technical Development: 15%
* Database Management: Lead oversight of data input and management and the development of Source Documentation to ensure data collection tools align perfectly with the protocol. In collaboration with biostatistics team, establish and maintain best practices for data collection, integration, and transfer.
* Data Quality Control: In collaboration with the regulatory team, ensure data integrity by monitoring for missing or incomplete data, reconciling survey data, and ensuring the accuracy of lab data imports.
* MOP Contribution: Provide expert operational input into the development and continuous updating of the Manual of Operations (MOP).

Clinical Coordination Support (Back-up): 5%
* Contingency Execution: Perform direct participant-facing coordinator work as needed to provide back-up coverage, ensuring study continuity during absences or surge periods.

Please include a cover letter and resume with application materials.

Required Qualifications:

* BA/BS in health-related field plus 6 years or more of research experience as lead study coordinator (or equivalent) in a biomedical health-related field OR advanced degree plus at least four years of relevant experience
* Experience coordinating and managing clinical trials; demonstrated ability to independently manage a research protocol
* Experience with clinical research Electronic Data Capture (EDC) systems.
* Experience with Good Clinical Practices (GCPs), Institutional Review Boards (IRB), and other regulatory requirements
* Demonstrated/documented record of advanced written, verbal, and interpersonal skills
* Demonstrated detail-orientation with exceptional organizational, planning and problem-solving skills
* Demonstrated ability to work independently, as a part of a team and with changing priorities
* Demonstrated ability to maintain deadlines and prioritize assignments
* Demonstrated ability to initiate and process multiple issues simultaneously
* Supervisory experience

Preferred Qualifications:

* Master's degree in health-related field
* Experience working in an academic medicine setting
* Experience working with children in the context of health-related initiatives/projects
* Experience with FDA-specific regulatory activities

Pay Range: $90,000 - $105,000, depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Faculty and P&A Staff

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

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

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will have the opportunity to complete an online application for the position and attach a cover letter and resume or CV.

This position will remain open until filled.

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

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

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.

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.

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