The individual will be responsible for Quality Assurance (QA) monitoring of cooperative group-, industry-sponsored, and investigator-initiated clinical trials, and. Ensuring that trials are conducted, recorded, and reported in accordance with the protocol, applicable regulatory requirements, Good Clinical Practice (GCP), and institutional standard operating procedures (SOPs). Study monitoring will be performed through study feasibility, study start up, site initiation visits (SIV), interim monitoring visits (IMV), real-time internal monitoring, and close out visits (COV) as assigned by the Sr. Research Compliance Officer. The individual will work closely with principal investigators (PI) and the research teams throughout the monitoring process as needed; guide and direct PIs and research teams as appropriate and when there are significant concerns or issues identified, provide real-time education and support to the PIs and research teams when needed. Meet with PIs and research teams to review monitoring findings and development of Corrective Action Plan(s), if required. Support QA Leadership in drafting summary monthly and quarterly reports, discussing potential workflow improvements or solutions, evaluating verification procedures, etc. Other duties as assigned. Education Description Minimum Required Preferred/Desired
3 years of clinical research experience monitoring clinical trials with a pharmaceutical company, at a clinical research site, contract research organization (CRO), or equivalent.
6 years of clinical research experience monitoring clinical trials with a pharmaceutical company, at a clinical research site, contract research organization (CRO), or equivalent. Training Description Minimum Required Preferred/Desired
Knowledge of medical terminology; previous experience in the healthcare setting; SOCRA or ACRP certification required within 2 years of hire.
SOCRA or ACRP certifications; experience in Oncology Clinical Research. Special Skills Description Minimum Required Preferred/Desired
A keen eye for detail; excellent communication and organization skills. Computer skills to include Microsoft Office Word, Excel, and PowerPoint. Experience with electronic medical records (EMR) systems; electronic data capture systems, and clinical trial management systems. Excellent skills in English (both verbal and written) is required