Rsch Pro 3-Rsch Coord-Cln I/T

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.

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.

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 tochanging priorities based on most critical need
• Demonstrated ability to maintain deadlines and prioritize assignments
• Relevant research certification, such as CCRP or CCRC
• Master'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

Pay Range: $65,000 - $75,000/year; depending on education/qualifications/experience

Time Appointment: 75%-100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

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

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.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).

The University of Minnesota Medical School

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.
The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.

Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.