The primary purpose of this position is to coordinate and support our pediatric research initiatives in Peds Critical Care (PICU/CVICU) according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data, sample management, and responding to data queries. This position reports to the Clinical Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the research team.
With your application, please include a cover letter that summarizes why you are interested in working with critically ill children.
Responsibilities:
Clinical Research Conduct & Facilitation (55%)
- Lead a large and/or complex project, or portfolio of projects with assistance from the project manager or other leaders, as needed.
- Act as an information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
- Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue.
- 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.
- Contribute to the production of research publications or presentations of research data.
- Lead study team meetings as well as meetings with stakeholders engaged in the clinical research study.
- Maintain overall knowledge of individual study tasks as well as higher level oversight of clinical research studies.
Research Regulatory Management (30%)
- Serve as the primary contact for the completion of required regulatory documentation.
- Prepare regulatory approval applications; 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.
- 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.
- Prepare for and participate in site qualification visits, site initiation visits, monitoring visits, program audits, etc.
- Report Unanticipated Problems according to University policy.
Administration & Education (15%)
- Facilitate new project development and start-up activities.
- Support quality improvement initiatives.
- Facilitate Pre-award and Post-award grant administration.
- Attend national professional organization meetings and investigator meetings as appropriate.
- Support the training and mentoring of CRCs within the program and across the pediatrics department.
- Educate University faculty and staff on our regulatory and research obligations in relation to pediatric clinical research activities.
- Communicate with and provide education to clinical teams to foster an environment of quality research participation within the context of exceptional clinical care.
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 - RPB and Children's Hospital
All required qualifications must be documented on application materials.
Required Qualifications:
- BA/BS in a scientific or health related field and 4 years research experience, OR advanced degree plus 2 years research experience, OR a combination of education and experience in research to equal to 8 years.
- At least 2 years experience conducting clinical research, preferably at the University of Minnesota.
- Experience working with patients and families, preferably within a hospital setting and/or pediatric populations.
- Ability to work flexible work hours, including occasional evening and weekends.
- 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:
- Relevant research certification, such as CCRP or CCRC.
- Effective prioritizing responsibilities with ability to change priorities with emerging needs.
- Demonstrated ability to maintain deadlines.
- Excellent written, verbal and interpersonal skills.
- Knowledge of federal regulations related to research with human subjects and protected health information.
- Experience with computerized data management in a health-related setting.
- Demonstrated specimen management skills, including processing human samples and shipping per regulations.
- Detail-oriented with exceptional organizational, planning and problem-solving skills.
- Ability to work independently and as a part of a team.
- Experience with Epic electronic medical record system.
- Experience with pediatric populations.
- Demonstrated data management skills, including data collection, generating reports, and ensuring data quality.
- Computer proficiency and ability to navigate multiple software applications.
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