Advanced Practice Professional; NP​/PA), Clinical Research, Morristown

Conducts physical examinations, takes medical histories, orders and interprets lab tests, reviews, assesses, and reports diagnostic lab values and adverse events to physicians and sponsors. Provides patient follow-up and performs advanced assessments on study participants as needed.

Assumes responsibility for ensuring clinical trials are conducted according to Good Clinical Practices (GCP) guidelines.

Monitors patient safety during clinical trials, assesses, reports, and documents all adverse events and serious adverse events in compliance with regulatory, sponsor requirements, and policies.

Writes study drug prescriptions for trial subjects in accordance with applicable laws, sponsor guidelines, and SOPs.

Maintains subject study files, documents progress per GCP standards, manages study drug/device accountability records, and completes case report forms accurately and promptly.

Provides education to patients and caregivers regarding investigational products/devices and protocol requirements.

Acts as an advocate for patients.

Ensures study compliance with local and federal laws and regulations.

Implements study activities, ensures training and activation, communicates protocol requirements with healthcare team, and ensures adherence to protocols and SOPs.

Participates in recruitment and enrollment of study subjects.

Oversees data collection and documentation for quality and compliance, collaborates on informed consent and SAE reporting, and manages protocol deviations.

• Master's Degree required
• CCRC, CCRP preferred
• APN required