Conducing physical examinations, taking histories ordering and interpreting lab tests, reviewing, assessing and reporting diagnostic lab vales and adverse events to the physicians and the sponsor in addition to providing patient follow-up, and other advanced assessments on study participants as needed
Assume responsibility for assuring that clinical trials are conducted according to Good Clinical Practices guidelines
Monitors patient safety on clinical trials. Assesses, reports and documents all adverse events and serious adverse events per regulatory requirements, sponsor requirements and policies and procedures.
Writes study drug prescriptions for trial subjects in accordance with applicable state laws, sponsor guidelines and project standard operating procedures.
Maintains subject study files. Documents subject progress according to good clinical practices in research records. Maintains study drug/device accountability records as required. Completes required case report forms in an accurate and timely manner.
Provides relevant patient and caregiver education with regard to investigational products/devices and protocol requirements.
Serves as an advocate for patients.
Responsible for ensuring study is compliance with local and federal laws and regulations
Study Implementation. Ensures activation and training activities have occurred. Presented at the appropriate committee meetings (if department required), Communicates all protocol requirements with the healthcare team. Obtains documentation of such training and communication. Ensures study related activities are conducted per protocol and SOPs.
Recruitment and Enrollment
Quality and Compliance: Performs and oversees data collection and documentation in compliance with SOPs and GCPs. Facilitates/collaborates with regulatory staff on informed consent document, internal SAE reporting and protocol deviations; demonstrates proper management of adverse events.