What are the responsibilities and job description for the Clinical Research Coordinator II position at NemoursCareerSite?
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.