Clinical Research Coordinator-Neonatal

Children's Minnesota; Saint Paul (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

Children’s Minnesota is seeking a Clinical Research Coordinator for the Neonatology program. The role coordinates studies, ensures protocol compliance, and supports grant and budget activities. You'll interact with families for consent, manage data, and communicate with investigators and monitors.

The CRC collaborates with the Research Program Manager to implement studies on site between St Paul and Minneapolis, with a focus on pediatric research and GCP standards.

Qualifications

• Baccalaureate in a health-related field and at least four years of clinical research-related experience; or registered nurse with a current license and at least two years of clinical research experience; or two years of clinical research experience and a master's degree.
• At least one year of experience working with children is preferred. SoCRA or ACRP certification preferred.
• Detail-oriented with strong writing, communication, and computer skills; ability to manage multiple projects.

Responsibilities

• Organize and manage all aspects of assigned research activities per study protocols.
• Contribute methodological and technical expertise in design, implementation, analysis and reporting of research.
• Prepare regulatory submissions to the IRB and ensure compliance with GCP guidelines.
• Provide support to grant preparation and budget management.
• Facilitate and manage study-related communications with investigators, collaborators, regulatory bodies and site monitors.
• Interacting with patients and families for consent, scheduling visits and data collection.
• Oversee data collection and entry processes.
• Support personal career development and administrative tasks.

Skills

Regulatory knowledge

Written communication

Data management

Project coordination

Education

Baccalaureate in health-related field

RN license (current)

Master's degree in related field

Tools

Microsoft Office

Data capture systems

IRB submission software

Job description

About Children’s Minnesota

Children’s Minnesota is one of the largest pediatric health systems in the United States and the only health system in Minnesota to provide care exclusively to children, from before birth through young adulthood. An independent and not-for-profit system since 1924, Children’s Minnesota is one system serving kids throughout the Upper Midwest at two free-standing hospitals, nine primary care clinics, multiple specialty clinics and seven rehabilitation sites. As The Kids Experts™ in our region, Children’s Minnesota is regularly ranked by U.S. News & World Report as a top children’s hospital. Find us on Facebook @childrensminnesota or on Twitter and Instagram @childrensmn. Please visit childrensMN.org.

About Children’s Minnesota

Children’s Minnesota is one of the largest pediatric health systems in the United States and the only health system in Minnesota to provide care exclusively to children, from before birth through young adulthood. An independent and not-for-profit system since 1924, Children’s Minnesota is one system serving kids throughout the Upper Midwest at two free-standing hospitals, nine primary care clinics, multiple specialty clinics and seven rehabilitation sites. As The Kids Experts™ in our region, Children’s Minnesota is regularly ranked by U.S. News & World Report as a top children’s hospital. Find us on Facebook @childrensminnesota or on Twitter and Instagram @childrensmn. Please visit childrensMN.org.

Children’s Minnesota is proud to be recognized by Modern Healthcare as one of 2023’s Top Diversity Leaders. The national honor recognizes the top diverse healthcare executives and organizations influencing public policy, care delivery, and promoting diversity, equity and inclusion in their organizations and the industry.

Department Overview

Children’s Minnesota Neonatology is the largest in Minnesota and one of the largest in the country welcoming over 2,300 babies every year. Research for this department operates on Minneapolis and St Paul campuses, providing a range of level II to level IV clinical care with 180 beds and approximately 2,300 admissions per year. Neonatal research includes a mix of business and industry sponsored studies as well as investigator-initiated internally and externally funded studies, both observational and interventional projects.

Position Summary

The Clinical Research Coordinator (CRC) serves as the project manager for assigned projects and works directly with the Research Program manager and Clinical Research Associates I & II to coordinate and implement studies.

Responsibilities Include But Are Not Limited To The Following

• Organize and manage all aspects of assigned research activities and ensure compliance with study protocols and overall clinical research objectives
• Contribute methodological and technical expertise in the design, implementation, analysis and reporting of research
• Prepare regulatory submissions to the Institutional Review Board, and maintain compliance with all federal and local agencies in accordance with Good Clinical Practice guidelines
• Provide support to the preparation and management of grants
• Perform budget preparation and management, as needed
• Facilitate and manage study-related communications (including, but not limited to communication with investigators, collaborators, regulatory bodies, and site monitors)
• Proficiency at Interacting with patients and families for securing informed consent, scheduling research visits, and collection of data
• Oversight of data collection and entry processes
• Manage personal career development and administrative tasks

Location: Onsite between St Paul and Minneapolis

• Baccalaureate in a health-related field and at least four years of clinical research-related experience; or registered nurse with a current license to practice, and at least two years of clinical research experience; or two years of clinical research-related experience and a master's degree in a related field.
• At least one year of experience working with children is preferred. SoCRA or ACRP certification preferred.
• The CRC must be a detail-oriented person with strong writing, communication, and computer skills; (s)he must have the ability to manage multiple projects.

Promotion to next higher level, typically Senior Clinical Research Coordinator (SCRC), is determined by the Clinical Research Program Manager through performance reviews that take into account both experience carrying out the department's job-related duties/tasks, as well as a demonstrated commitment to professionalism in carrying out those tasks in line with Children's values and organizational policies and procedures.

Physical Demands

Please click here to view the Physical Demands

The posted salary represents a market competitive range based on salary survey benchmark data for similar roles in the local or national market. Annual salaries displayed are based on full-time employment (40 standard hrs per week). Annual salaries for part-time positions will be prorated based on the employee’s scheduled weekly hours in relation to the full-time standard. When determining individual pay rates, we carefully consider a wide range of factors including but not limited to market indicators for the specific role, the skills, education, training, credentials and experience of the candidate, internal equity and organizational needs.

In addition to your salary, this position may be eligible for medical, dental, vision, retirement, and other fringe benefits. Positions that require night, weekend or on-call work may be eligible for shift differentials or premium pay.

All job offers are contingent upon successful completion of an occupational health assessment, drug screen, background investigation, and compliance with the U.S. Government Form I-9, Employment Eligibility Verification.

Children’s Minnesota is proud to be an equal opportunity employer whose staff is representative of its community and considers qualified applicants for open positions without regard to race, color, creed, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.