Clinical Research Coordinator (Non-RN) - Research & Clinical Management

About the role

Under supervision, the Clinical Research Coordinator will assist with multiple clinical research studies involving human subjects within the research unit/department. Responsibilities include assisting with initiation, implementation, and management of research projects in accordance with GCP, FDA, HIPAA, and all required regulatory guidelines, with an emphasis on pediatric clinical research studies.

Responsibilities

• Initiate and manage multiple research projects, including clinical trials, PI-initiated studies, and other research projects.
• Submit protocols and renewals to IRB and scientific review boards.
• Manage and submit electronic data forms to sponsors, CROs, and regulatory agencies.
• Screen for eligibility and monitor and report adverse events, toxicities, and protocol deviations in a timely manner.
• Schedule subjects' visits and coordinate clinical, laboratory, and data management activities.
• Process and submit laboratory specimens.
• Interface with patients/subjects, Principal Investigators (PI), and assigned division's inpatient and outpatient clinical staff, as well as other departments within the institution.
• Coordinate preparation for monitor visits, regulatory, and data audits.
• Support and/or supervise interns or staff depending on the nature of the study.
• Collect basic vitals and clinical data based on study needs under the supervision and training of the study PI, if required by the study-specific research protocol.

Requirements

• Bachelor's Degree in a field related to the position.
• At least 2 years of experience in research or research-related activities.
• Excellent oral and written communication skills.
• General understanding of computer software and hardware, including Word, Excel, and data entry platforms (e.g., REDCap, Medidata, Rave).

Preferred Qualifications

• Master's Degree.
• 3 years of experience in research or research-related activities.
• Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent clinical research certification through SOCRA or ACRP.
• Demonstrated ability and past experience in complex analysis and 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.

Pay

The current salary range for this position is $34.14 to $46.94 per hour. Rady Children’s Hospital conducts regular market reviews to remain competitive with organizations of similar size in the nonprofit, healthcare sector. Compensation decisions consider experience, education, licensure, unique skillsets, organizational need, and internal equity.