The Clinical Research Monitor will evaluate, support and assure compliance and ethical conduct of BHSF investigator-initiated trials (IITs). Monitoring is performed in accordance with study specific clinical data monitoring plans developed for each study in accordance with institutional policies and procedures, and applicable regulatory requirements.This position will prepare monitoring reports for all visits conducted, managing action items and interfacing with members of the study project team. Duties require application of CFR, ICH, institutional SOPs, applicable local laws and statutes, and oncology knowledge (MCI).The monitor will serve as a member of the study project team, escalating as appropriate and engaging the lead-investigator/sponsor-investigator, BHSF leadership, informatics, data management, project management and others as needed to assure the protection of subject's rights, safety, and well-being as well as the quality and integrity of clinical trials.
Certified Research Healthcare Compliance (CHRC) preferred. Ability to problem solve and multi-task, excellent computer skills. Proficient in Windows, MS Word, Excel.
Possesses knowledge of Good Clinical Practices Manual, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions. Knowledge of basic human anatomy, physiology, medical terminology. Prior experience in Oncology preferred. Ability to communicate effectively and with a high level of professionalism across various stakeholders.
Baptist Health South Florida