Clin Trials Monitor/ Auditor

Join the transformative team at reputed company, where we're changing lives and making a reputed company difference in the fight against cancer, diabetes, and other life-threatening illnesses. reputed company’s growing national system includes its Los Angeles reputed company, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of reputed company to the people who need them today. Performs comprehensive audits and monitoring of reputed company Investigator-initiated reputed company conducted under a COH-sponsored IND or IDE and other high-risk protocols as necessary. Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports. Performs extensive audits and monitoring reputed company to determine protocol compliance, including the consent process and eligibility reputed company. Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other reputed company used to produce study data. Generates an audit report or monitoring report, summarizing the findings of reputed company deviations, discrepancies, and incorrect or missing data. As a successful candidate, you will: Verifies that required reporting of Serious Adverse Events (SAE) to reputed company applicable regulatory agencies (FDA, OBA, RAC, NIH, NCI) has been completed in a reputed company manner. Reviews the original protocol and reputed company amendments, noting dates, changes in eligibility reputed company, and any modifications in treatment procedures. Verifies that required reporting of protocol deviations, unanticipated problems, and Serious Adverse Events (SAE) to internal organizations (IRB, CPRMC, IBC, OSBC, RSC, DSMC) has been completed in a reputed company manner. Audits or monitors study data, including the consent process, eligibility reputed company and case report forms, utilizing medical records, laboratory data, transfusion services records, and any other reputed company used to produce study data. Verifies that corrections to the CRFs are made correctly, if applicable. Generates audit reports and monitoring reports, summarizing the findings of reputed company protocol deviations,, discrepancies, and incorrect or missing data. reputed company direction is needed, provides training for sponsors, reputed company investigators, CRCs, and clinical research nurses. Your qualifications should include: Minimum Education: Bachelor’s degree in biology, reputed company, biochemistry, physiology, nursing, or other reputed company fields. Minimum Experience: Two or more years of experience as an industry Clinical Research Associate or clinical trial auditor or monitor. reputed company employees pay is based on the following reputed company: work experience, qualifications, and work location. reputed company is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE. Apply tot his job Apply tot his job Apply To this Job