The Pediatric KIDney Stone (PKIDS) Care Improvement Network, which is a community of patients, caregivers, and clinicians who perform collaborative studies of kidney stones at 23 pediatric healthcare systems in the United States, seeks to generate and apply knowledge that improves the lives of pediatric patients with kidney stones. This PCORI-funded 12-week follow-up prospective cohort study will compare stone clearance and patients' experiences for the three existing surgical treatments to remove stones: ureteroscopy (URS), shockwave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL) across PKIDS. The resultant knowledge of these patient-centered outcomes will improve pre- and intra-operative decision-making about the surgical management of stones.
This individual will coordinate and help implement operations related to the main study, oversee regulatory activities, and supervise recruitment efforts across PKIDS sites. He/she would also assist with coordination of ancillary study activities related to both the PKIDS Network and general research program.
- Assist with supervision, training, and support of staff to ensure compliance with study protocol, NIH and FDA policies. Includes onboarding personnel.
- Work collaboratively and effectively with the individual study management teams, various core groups at CHOP’s Research Institute and other participating institutions.
- As part of study team, develop, review, and update program policies and procedures as needed.
- Facilitate and/or run research/project team meetings
- Monitor or audit study activities internal and external to CHOP, execution of quality management processes.
- Serve as a liaison between Research and other Hospital staff to carry out the needs of the research project(s).
- Assist with study database management, analysis of data, and preparation of manuscripts and scientific presentations, as needed.
- Lead regulatory efforts, including management of IRB documentation, protocol amendments, etc.
- Responsible for Regulatory compliance for clinical research program, including tracking regulatory compliance of external sites.
- Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.
- Provide supervision and support for other clinical research coordinators and or/ monitors who are assigned to specific protocols and who will help with the overall clinical research of the program.
- Screens, recruits, and enrolls patients/research participants
- Primary contact for trial for internal and external participants.
Required Education and Experience
Required Education: Bachelor’s Degree in related field
Required Experience: Five (5) years of relevant clinical research coordination experience
Preferred Education, Experience & Cert/Lic
Preferred Education: Master’s degree in a related field
Preferred Experience: Seven (7) years of relevant clinical research coordination experience
- Completion of Good Clinical Practice (GCP) training
- Society of Clinical Research Associates – SoCRA membership or Association of Clinical Research Professionals – ACRP membership
Additional Technical Requirements
- Excellent verbal and written communications skills
- Excellent time management skills
- Ability to collaborate with stakeholders at all levels