Do you envision finding a meaningful role with an inclusive and compassionate team? At Children’s Mercy, we believe in making a difference in the lives of all children and shining a light of hope to the patients and families we serve. Our employees make the difference, which is why we have been recognized by U.S. News & World Report as a top pediatric hospital, for eleven consecutive years.
Children’s Mercy is in the heart of Kansas City – a metro abounding in cultural experiences, vibrant communities and thriving businesses. This is where our patients and families live, work and play. This is a community that has embraced our hospital and we strive to say thanks by giving back. As a leader in children’s health, we engage in meaningful programs and partnerships throughout the region so that we can improve the lives of children beyond the walls of our hospital.
OverviewThe Research Quality Monitoring and Regulatory Affairs Manager provides programmatic direction and strategic planning for 2 key functions including the Office of Clinical Research Management and Support's Research Quality Monitoring Program(RQMP) and Regulatory Affairs Program(RAP). The incumbent manages and works collaboratively with Specialists, Research Quality Monitoring Program and CM research enterprise stakeholders to conduct robust quality monitoring which assesses the conduct of IRB approved human subject studies for compliance with applicable regulations, accepted standardizing guidance(GCP, GLP, GMP, etc..) and institutional policies. With the approval and support of the Senior Director of the Office of Clinical Research Management and Support, the incumbent develops, recommends, and implements RQMP policies and/or best work practices that drive stewardship and excellence in research. The incumbent integrates technology tools to facilitate RQMP services and serve as a quality improvement resource for investigators and their study teams. The RQMP Manager collaborates cross-functionally to improve research conduct throughout the institute and hospital. The RQMP Manager consults and educates research teams throughout the institution, and collaboratively develops curriculum and standards for the conduct of research. The incumbent continually benchmarks to industry best practices and evidence-based quality processes. The incumbent manages and collaborates with the Regulatory Affairs Specialist responsible for creating, submitting, and managing Clinicaltrials.gov filings and FDA registrations and support throughout the institution. The manager ensures objectives of both the RQMP and RAP are met on a continuous basis and reviews feedback in an effort of continuous improvement. The incumbent contributes to ORI, Research and Sponsored Projects Administration, and Office of Clinical Research Management and Support work initiatives as assigned.
At Children’s Mercy, we are committed to ensuring that everyone feels welcomed within our walls. A successful candidate for this position will join us as we strive to create a workplace that reflects the community we serve, as well as our core values of kindness, curiosity, inclusion, team and integrity.
Additionally, it’s important to us that we remain transparent with all potential job candidates. Because we value the safety of the patients and families we serve, as well as the Children’s Mercy staff, we want to let you know that the seasonal influenza vaccine is a condition of employment for all employees in our organization. New employees must be willing to be vaccinated if found non-immune to measles, mumps, rubella (MMR) and chicken pox (varicella) and/or without evidence of tetanus, diphtheria, acellular pertussis (Tdap) vaccination since 2005. If you are selected for this position, you will be asked to supply your immunization records as proof of vaccination. If you and have any concerns about receiving these vaccines, medical and/or religious exemptions can be further discussed with Human Resources. Responsibilities Supervise and maintain RQMP and RAP regular operations.Manage RQMP and RAP effectiveness and results, lead its continuous improvement and assure alignment with Children's Research Institute aims.Assist the Sr. Director of Clinical Research Management and Support(CRMS) as assigned.Personnel Management Qualifications Master's Degree Master's Degree preferred; business administration or project management emphasis preferred and 3-5 years experience 1+ years of personnel management and leadership experience preferred or Bachelor's Degree Bachelor's Degree required; clinical or life sciences emphasis preferred and 5-7 years experience Research administration and project management experience in a related health care setting; knowledge of all levels of regulatory requirements and quality guidelines in the conduct of clinical research Experience and knowledge of utilizing clinicaltrials.gov, and applicable regulations for maintaining compliance to FDAAA and NIH policy. Experience and knowledge of submission/maintenance of FDA registrations. Knowledge of GxP including: Good Clinical Practice, Good Manufacturing Practice, and Good Laboratory Practice. Research quality management training Preferred Benefits at Children's MercyThe benefits plans at Children’s Mercy are one of many reasons we are recognized as one of the best places to work in Kansas City. Our plans are designed to meet the changing needs of our employees and their families.
Learn more about Children’s Mercy benefits. Starting Pay
Our pay ranges are market competitive. The pay range for this job begins at $34.51/hr, but your offer will be determined based on your education and experience.
Remote Work/Work from Home
This is an intermittent remote position, which means that the person hired will work with his or her manager to determine a schedule that includes both at home and on-site hours at a Children’s Mercy location. The incumbent must live in the Kansas City metro area.
EEO Employer/Disabled/Vet
Children’s Mercy hires individuals based on their job skills, expertise and ability to maintain professional relationships with fellow employees, patients, parents and visitors. A personal interview, formal education and training, previous work experience, references and a criminal background investigation all are factors used to select the best candidates. The hospital does not discriminate against prospective or current employees based on the race, color, religion, sex, national origin, age, disability, creed, genetic information, sexual orientation, gender identity or expression, ancestry or veteran status. A drug screen will be performed upon hire. Children’s Mercy is smoke and tobacco free.
Our commitment to Diversity & Inclusion
CM is committed to creating a diverse and inclusive workforce. Our patients and families come from all walks of life, and so do we. We know that our greatest strengths come from the people who make up our team so we hire great people from a wide variety of backgrounds, not just because it’s the right thing to do, but because it makes our hospital stronger and our patient care more compassionate.
If you share our values and our enthusiasm for service, you will find a home at CM. In recruiting for our team, we welcome the unique contributions that you can bring, including education, ideas, culture, ethnicity, race, sex, sexual orientation, gender identity and expression, national origin, age, languages spoken, veteran status, color, religion, disability and beliefs.
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