Clinical Research Project Manager

Position Overview

This role will manage studies led by the supervisor and PI, Dr. Sandra Japuntich. The primary purpose of this position is to manage a portfolio of human subjects research from concept to study closeout focused on tobacco cessation treatment development, effectiveness, and implementation. Duties are determined by protocol-specific requirements. These may include analyzing study feasibility, developing study specific materials, overseeing recruitment and enrollment of study subjects, overseeing study data collection, managing regulatory documents and required reporting, and supervising study staff. The first task will be to serve as a project manager for a recently funded PCORI trial to test models to deliver tobacco use disorder treatment in community mental healthcare settings across 4 states. https://www.pcori.org/research-results/2026/strategies-treat-tobacco-smoking-community-mental-health-care

Duties/Responsibilities

35%: Manages study protocol from concept to study closeout. Works collaboratively to analyze study feasibility, develop study specific materials, ensure that staff are trained on delegated tasks and responsibilities. Facilitates execution of protocol. Collaborates with research study staff (Investigators, Coordinators, etc.) to review the study protocol and develop the study budget to ensure that all relevant study costs have been included. Ensures timely processing of all pre-award steps to avoid delays in starting trials. Compares protocol and contract documents for consistency. Acts as a liaison with the Sponsored Project Administration (SPA) department and academic department finance/administration to facilitate communications, ensure document submissions, and resolve any contract issues. Works to ensure a smooth transition between pre-award and post-award project phases, including transition to post-award accountants. Works with post-award accountants to ensure accurate invoicing and contracting is completed.

35%: Executes the implementation of the study protocol. Duties are determined by protocol-specific requirements. These may include overseeing recruitment and enrollment of study subjects, ensuring compliance with the protocol and continuity of care for the research subject from screening to completion of the study. Safeguard that study data is complete, timely and accurate. This position involves supervision of 1-3 study staff members involved in study recruitment, and assessment of study outcomes.

20%: Operates as a liaison between Principal Investigator, University departments, outside sponsors, clinical partners and collaborators. Provides expertise in technical trouble shooting and safety issues. Serves as a resource for staff, vendors and study sponsors. Works to identify, develop, discuss, and implementing new procedures. Participate in the training of new staff.

5%: Formulates accurate data reporting and works with Principal Investigator to monitor the well-being and safety of the research participant. Responsible for interpretation of, application of, and compliance with Federal Regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as it relates to assigned research protocols.

5%: Prepares timely submission of study/regulatory documents (IRB, clinicaltrials.gov, sponsor reporting). Evaluates adverse event data and advise making submission requests.

Qualifications

Required Qualifications

• BA/BS with at least 5 years of experience, an advanced degree plus at least 3 years of relevant experience, or a combination of education and relevant work experience to equal at least 9 years.
• Experience managing clinical trials.
• Experience in reporting to funding agencies, and clinicaltrials.gov
• Experience working with IRBs including experience monitoring, managing and reporting Adverse Events.

Preferred Qualifications

• Supervisory experience.
• Ability to follow strict protocols with utmost ethical standards.
• Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies.
• Experience working on multi-disciplinary teams.
• Possess excellent communication skills; verbal and written.
• Excellent interpersonal communication skills with patients and other healthcare professionals.
• Certified Clinical Research Coordinator (ACRP or SOCRA), strongly preferred.
• Experience managing multisite clinical trials
• Experience with electronic case report form completion with experience with REDCap preferred.
• Experience working on trials funded by the Patient Centered Medical Outcomes Research Institute (PCORI)
• Experience with community-engaged research
• Previous management of multiple externally funded projects simultaneously
• Fluency in Spanish

About the Department

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.

The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.

Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.

Pay and Benefits

Pay Range: $43.27 - $48.08 per hour ($90,000 - $100,000 annually); depending on education/qualifications/experience

Time Appointment: 100% A ppointment

Work Location: Remote

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

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.

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 jobcentr@umn.edu.