Research Pro 1-Rsch Coord-Cln I/T - Military Veterans

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 Children'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.â
• Ensure timely and accurate dataâcollection andâsubmission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.â
• Process human specimens per protocol requirements, coordinate shipping as neededâ
• Conduct data abstraction for chart review studiesâ

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

All required qualifications must be documented on application materials

Required Qualifications:

• BA/BS preferably in a scientific or health related field, OR a combination of education and experience in research to equal to 4 years
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently and as a part of a team and with changing priorities
• Demonstrated ability to maintain deadlines and prioritize assignments
• Demonstrates excellent written, verbal and interpersonal skills
• 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.

Preferred Qualifications:

• Experience with computerized data management and abstraction, preferably in a health-related setting, including electronic medical records
• Experience working in an academic medicine or pediatric acute medical setting. Comfortable with interfacing with clinical care teams and potential research participants
• Knowledge of Good Clinical Practices (GCPs) and federal regulations related to clinical research
• Specimen management skills, or willingness to learn (including processing human samples and shipping per regulations)
• Ability to work flexible work hours, including occasional evening and weekends