Research Pro 1-Rsch Coord-Cln I/T

Our program seeks a Clinical Research Coordinator, Level I, who will be responsible for the coordination and data management of assigned clinical research studies. Persons in a CRC I position in this division will primarily be assigned to data and sample collection studies, such as the Childrenâ™s Oncology Group Registry â“ Project: Every Child. This international registry of infants, children, adolescents, and young adults with cancer supports current and future therapeutic clinical trials and the future research efforts for better treatment and care. This position will also support other research studies/trials and partner with other team members to meet project goals and outcomes. Duties include  coordinating the enrollment of eligible patients, extracting and reporting quality patient data, managing research sample collection and submission, and consenting participants for local sample collection studies.  This position reports to the Clinical Research Program Manager, but is accountable to the physician-investigators and members of the research team. 

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.   

Position is hybrid between remote and in person/on campus work. 

Location: UMN Mayo Building; Masonic Children's Hospital
 

Responsibilities:

Clinical Research Conduct & Facilitation (85%) 

• Coordinate study-related activities, including participant recruitment, enrollment, study visits, data and specimens, and sponsor visits.  
• Act as information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.⯠
• Ensure timely and accurate dataâ¯collection andâ¯submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.⯠
• Process human specimens per protocol requirements, coordinate shipping as needed⯠
• Conduct data abstraction for chart review studies⯠

Regulatory (10%) 

• Partner with Regulatory Specialist, the PI and  study team to ensure ethical conduct of clinical trials  
• Provide documentation and reports related to study participation to the regulatory team to ensure compliance with applicable policies, procedures and regulations 
• Support the Investigators in ensuring the protection of all human research participants according to Federal regulations, University policies, and sponsor expectations 

Education & Administration (5%) 

• Attends study meetings and research education sessions 
• Educate University faculty and staff of our regulatory and research obligations in relation to our clinical research activities