Pediatric Orthopedic Clinical Research Coordinator II

Ortho Conditioning; Wilmington (DE); On-site; USD 55,000 - 75,000; Full time

Job summary

Nemours Children’s Health is seeking a Clinical Research Coordinator II in Wilmington, DE to coordinate and implement orthopedic clinical trials. You will assist in regulatory document preparation, recruit study participants, obtain consent, educate families, and schedule procedures per protocol.

Responsibilities include data collection, maintaining study records, interfacing with sponsors, and participating in audits and sponsor visits.

Qualifications

• Bachelor’s degree in medical or science related field required.
• 3–5 years research experience.
• Clinical Research Coordinator certification or eligibility to sit for exam and minimum 2 years coordination experience.
• Effectively uses Microsoft computer software.
• Demonstrates ability to coordinate and prioritize among diverse tasks.
• Excellent verbal and written communication skills.

Responsibilities

• Follow SOPs and GCP; prepare documents required by sponsors and attend Investigator Meetings.
• Understand and conduct clinical studies including DSMB, Emergent Access, multi-site trials.
• Achieve CRC certification from ACRP or SOCRA.
• Develop source documents and regulatory submissions for IRB; create participant education tools.
• Coordinate parental permission/assent; schedule visits per protocol.
• Collect data; maintain accuracy, completeness and quality in databases.
• Mentor new coordinators and train staff on study procedures.
• Identify and report Serious Adverse Events; assist with medication accountability.
• Coordinate monitoring with sponsor; respond to sponsor queries and prepare for audits.
• Assist in regulatory documents and audits by IRB and FDA.

Skills

Verbal communication

Written communication

Prioritization

Coordination

Mentoring

Microsoft Office

Education

Bachelor’s degree in medical or science related field

Tools

Microsoft Office

Job description

Nemours Children’s Health is seeking a Clinical Research Coordinator II in Wilmington, DE to coordinate and implement orthopedic clinical trials. You will assist in regulatory document preparation, recruit study participants, obtain consent, educate families, and schedule procedures per protocol.

Responsibilities include data collection, maintaining study records, interfacing with sponsors, and participating in audits and sponsor visits.