Clinical Research Coordinator II

The Clinical Research Coordinator II (CRC II) independently coordinates and conducts complex clinical research studies, including those involving data safety monitoring boards, emergent access, investigator-initiated studies, and multi-site protocols.

This role includes developing IRB documentation, managing study databases, recruiting and consenting participants, and ensuring accurate reporting of serious adverse events.

The CRC II mentors new coordinators, collaborates with investigators, and contributes to training, education, and quality initiatives while modeling Nemours Standards of Behavior.

Qualifications:


* Bachelor's degree in medical or science related field required;


* Proficiency in Microsoft Office and EMR systems.


* Knowledge of Good Clinical Practice (GCP) and SOPs.


* Clinical Research Coordinator certification or eligible to sit for exam and a minimum of 2 years clinical research coordination experience


* A minimum of one year Clinical Research experience required

Primary Responsibilities:

Performs all duties of the Clinical Research Coordinator I, with expanded responsibilities for complex protocols and mentorship.

Understands and conducts clinical research studies involving DSMBs, emergent access, investigator-initiated studies, and multi-site trials.

Develops source documents, parental permission, and assent documentation for IRB submission.

Recruits, screens, and consents patients/participants in accordance with protocol and regulatory requirements.

Maintains accurate and up-to-date study databases, ensuring data integrity and timely query resolution.

Assists in identifying, reporting, and following up on serious adverse events, protocol deviations, and unanticipated problems.

Coordinates and schedules study visits and procedures per protocol requirements.

Prepares for and participates in internal and external audits, including sponsor monitoring visits and IRB inspections.

Mentors new clinical research coordinators and collaborates with investigators to ensure protocol compliance.

Participates in training, education, and quality initiatives, supporting continuous improvement and professional development.

About Us

Nemours Children's Health is an internationally recognized children's health system.

With more than 1.7 million patient encounters annually, we provide medical care in five states through two freestanding state-of-the-art children's hospitals - Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida.

Our pediatric network includes 80 primary-urgent-and specialty care practices and more than 40 hospitalists serving 19 affiliated hospitals.

We generate annual revenues of more than $1.7 billion derived from patient services, contributions from the Alfred I.

duPont Trust, as well as other income.

As one of the nation's premier pediatric health systems, we're on a journey to discover better ways of approaching children's health.

Putting...