JOB SUMMARY:

Under supervision, the Clinical Research Coordinator will be assigned to assist with multiple clinical research studies involving human subjects within the research unit/department. Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA & all required regulatory guidelines, with an emphasis on pediatric clinical research studies. Responsibilities may include initiating & managing multiple research projects, including but not limited to clinical trials, PI-initiated studies, and other research projects. Responsibilities may include but are not limited to: submission of protocols & renewals to IRB & scientific review boards; management & submission of electronic data forms to Sponsors, CROs & regulatory agencies; screening for eligibility; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data management activities; processing and submitting laboratory specimens. Interfaces with patients/subjects & the

Principal Investigators (PI) as well as working with assigned division's inpatient & outpatient clinical staff & other departments within the Institution. Coordinates preparation for monitor visits, regulatory & data audits. May support and/or supervise interns or staff depending on nature of study. If needed under study-specific research protocol, may collect basic vitals and clinical data based on study needs under the supervision and training of the study PI.

MINIMUM QUALIFICIATONS:

Bachelor's Degree

Area of Study in a Field Related to the Position

2 Years of Experience

At least 2 years of experience in research/research-related activities

Excellent oral and written skills

General understanding of computer software and hardware: Word, Excel, data entry (ex. Any EDC platform such as REDCap, Medidata, Rave)

PREFERRED QUALIFICATIONS:

Master's Degree

3 Years of Experience

Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent Clinical research certification through SOCRA for ACRP

Demonstrated ability and past experience in complex analysis, familiarity with statistical methodology

Additional experience with preparation and submission of IRB applications, regulatory correspondence, and/or specific content of study related research

1-2 years of clinical trial experience

The expected hiring range for this position is $32.51 to $44.70

Rady Children’s Hospital is committed to compensation that is externally competitive and internally equitable. We demonstrate this commitment by conducting regular market reviews to remain competitive with organizations of similar size in the nonprofit, healthcare sector. The range listed above does not represent the full salary range for the position but is the expected hiring range for qualified candidates. Compensation decisions consider a variety of factors including experience, education, licensure, unique skillsets, organizational need, and internal equity. This posting will remain open from the “date posted” until the hiring manager has determined there is a sufficient applicant pool or until the position is filled.