Clinical Research Coordinator

Position Summary:
The Clinical Research Coordinator provides overall study management for research faculty on a variety of research studies to include business and industry studies, investigator-initiated studies and NIH sponsored research. This position reports to the Dermatology Clinical Research Division Program Manager.

The research coordinator will manage research projects across the Department of Dermatology. The coordinator will be a member of the Department of Dermatology Clinical Research Division. In addition, the position collaborates with other areas of the University to include Clinical Transitional Science Institute (CTSI) clinical research services, and the staff in the Dermatology clinics, research clinics and research laboratories in assuring that studies meet regulatory requirements, policies and procedures and are completed according to study protocols.

This is a temporary position expected to last through June 14, 2026,, with the possibility of extension based on satisfactory performance, availability of work, and departmental/ grant funding.

Major Duties/Job Description:

Clinical Research Conduct and Facilitation (50%):

• Be primary contact and information resource to university faculty and staff for protocol specific queries, including enrollment requirements, specimens needed, etc.
• Engage with investigators and ensure research procedures comply with regulations, policies, and best practices.
• Provide effective specimen management, including preparing kits, processing specimens, preparing shipments, tracking inventory, etc.
• Work with investigators to ensure subject eligibility, facilitate subject enrollments, ensure the appropriate recording of adverse events, and timely acquisition of research tissue.
• Coordinate subject visits, ensure protocol requirements are met
• Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
• Facilitate the timely review and reporting of adverse reactions and severe adverse events
• Ensure compliance with requirements for registering subjects and study visits; facilitate compliant research billing of services
• Contribute to the production of research publications or presentations of research data
• Enter all study and subject data into OnCore clinical trials management system and required sponsor platforms

Research Regulatory Management (20%):

• Serve as the primary contact for the completion of required regulatory documentation
• Manage regulatory submissions and approvals; respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained. Track all regulatory review submissions to ensure deadlines are met.
• In collaboration with the PI, interpret study protocols and develop consent form documents needed for each clinical research study in conjunction with central CTSI regulatory assistance.
• Maintain regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time
• Provide regulatory guidance and direction to all members of the research team to ensure compliance with applicable policies, procedures, and regulations
• Ensure training requirements are met for all study team members
• Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
• Report Unanticipated Problems according to university policy

Recruitment of research subjects (15%):

• In collaboration with the PI ensure recruitment activities are in line with the population and reach the intended audience:
• Identify recruitment material needs for the study population
• Develop or modify existing recruitment material to reach the intended population
• Ensure recruitment plan is approved by the sponsor and IRB
• Ensure the recruitment materials are implemented (media, print and digital)
• Review recruitment plan throughout the study and adjust as needed
• Implement a pre-screening plan and enrollment flow for potential subjects

Administration (10%):

• Provide support and assistance to the clinical research team as directed.
• Support quality improvement initiatives
• Attend weekly clinical research meetings
• Facilitate new project development
• Facilitate Pre-award and post-award grant administration

Education (5%):

• Attend Research Professional Development Seminars and other educational opportunities as appropriate
• Engage with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
• Attend study, department education and national meetings to support the projects

All required qualifications must be documented on application materials.

Required Qualification:

• Bachelors' degree and 4 years of clinical or research experience, or advanced degree plus at least two years of relevant experience, or a combination of related education and work experience to equal 8 years.
• Relevant and direct experience in clinical research to include data management and following clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials and Good Clinical Practice guidelines.
• Experience in handling laboratory specimens and knowledge of good laboratory practices.
• Computer proficiency and ability to navigate multiple software applications.
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work in a complex environment
• Ability to work independently, as a part of a team and with changing priorities
• Possess excellent communication (written and verbal) and interpersonal skills
• Ability to work flexible work hours, potentially rare evenings and weekends.
• Knowledge of electronic regulatory management

Preferred Qualifications:

• Certified Clinical Research Coordinator
• Ability to multitask and manage projects simultaneously
• Experience reading and interpreting the scientific literature.
• Previous experience with Dermatology research, adult and pediatric studies
• Relevant and direct experience with regulatory requirements including study monitoring, Institutional Review Board submissions, Investigation New Drug (IND) and/or Investigational Device (IDE) submissions.
• Experience with Epic or other electronic medical record system
  

The Department of Dermatology is committed to providing excellent patient care, conducting investigational research and training the next generation of dermatologist. We have world-renowned clinical programs, nationally recognized educational program, and pioneering clinical trials. We are dedicated to improving dermatological care not only for today, but also for the future.

For more information, please visit our website at https://med.umn.edu/dermatology.

Pay Range: $33.08 to $35.48 per hour, we anticipate most offers will be around the midpoint of this range, depending on education and experience.

Time Appointment: 100% Appointment

Position Type: Civil-Service

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, pharmacy and disability plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• 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 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.

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.