The primary purpose of this position is to support clinical research projects in a variety of pediatric specialties according to regulatory requirements, institutional guidelines, and sponsor expectations.  Duties include leading studies, coordinating the enrollment of eligible patients, supporting research evaluations and measurements, extracting and reporting quality patient data and tissue samples, responding to data queries, and initiating new trials.  This position reports to the Research Project Manager, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.

Responsibilities:
Clinical Research Project Coordination & Start-Up (60%)

• Under the guidance of the project manager and/or other leaders, lead a large and/or complex project, or portfolio of projects.
• Coordinate patient participation in clinical research including screening and recruiting patients and families, ensuring study eligibility and enrollment, and scheduling and conducting research visits 
• Ensure timely and accurate data submissions, engage with providers and investigators to ensure adequate source documentation is available, accurate interpretation and recording of data, maintenance of subject research binders. 
• Facilitate the timely review and reporting of adverse reactions and severe adverse events.
• Specimen management for multiple projects including facilitating the collection of research specimens during routine clinical procedures, ensuring high quality processing of research specimens, and coordinating timely shipment of research specimens to research laboratories
• Be a resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc. 
• In collaboration with PIs and study teams, contribute to research publications or presentations.
• Serve in lead coordinator role for creation and implementation of the study protocol, procedures, manuals and tools for the study team. 
• Complete study start-up tasks in respective clinical trial management systems: Oncore, Florence, Ethos, Box, etc.
• Under the direction of the project manager participate in budget, contract and negotiation creation and communications.  

Research Regulatory Management (25%) 

• Serve as the primary contact for the completion of required regulatory documentation. 
• Prepare and maintain regulatory documents throughout the course of a study, from start-up to close-out; submitting and filing modifications including consent form changes, protocol amendments, updates to the Investigator's Brochures, continuing reviews, pre-screening phone script changes, letters to participants, etc.
• Manages communications with monitor/CRO/sponsor. Communicates findings and required changes with study team to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements. Files monitor reports with the central file (paper binder, Florence and HRPP) for clinical trial monitoring.
• Schedule, prepare for, and lead site qualification visits, site initiation visits, interim monitor visits, audits, etc.

Administration, Education & Professional Development (15%)

• Support the training and mentoring of research coordinators within Pediatric Clinical Research Services
• Create work tools to support coordinators in ensuring participant safety and meeting protocol and regulatory requirements to ensure uniformity.
• Create templates and processes for key study activities including source documents (CRFs and logs), collection and maintenance of adverse events, specimen collection and processing, etc.
• Attend both internal and external research related professional development opportunities, educational seminars and clinical research professional series, as appropriate. 

Essential Employees

The successful candidate will be designated as an Essential Employee. Essential Employees are expected to report to campus during a University State of Emergency (reduced operations or campus closure) unless specifically directed by the Department not to report or if directed by civil emergency or medical authorities not to report for health and safety reasons.  As an Essential Employee, you must report to campus even if the closure is less than 3 days.   

Work Location: Hybrid 

All required qualifications must be documented on application materials

Required Qualifications:

• BA/BS in a scientific or health related field plus at least 4 years of experience or advanced degree plus 2 years of experience or a combination of related education and work experience to equal 8 years.  
• Experience working with patients and families, preferably within a hospital setting and/or pediatric populations 
• Excellent written, verbal and interpersonal skills 
• Experience conducting clinical research, including recruiting participants and conducting study visits 
• Knowledge of federal regulations related to research with human subjects and protected health information 
• Demonstrated data management skills, including data collection, data entry and quality control 
• During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.â¯â¯â¯  

Preferred Qualifications:

• Experience with computerized data management in a health-related setting, including electronic medical records  
• Computer proficiency and ability to navigate multiple software applications  
• Detail-oriented with exceptional organizational, planning and problem-solving skills 
• Ability to work independently, as well as part of a team 
• Ability to adapt to changing priorities based on most critical need 
• Demonstrated ability to maintain deadlines and prioritize assignments 
• Relevant research certification, such as CCRP or CCRC 
• Masterâ™s Degree in related field
• Specimen management experience including processing human samples and shipping per regulations 
• Regulatory management experience including IRB submissions and regulatory binder maintenance 

About University of Minnesota Twin Cities

The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.

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