Regional CRA - Clinical Research Associate - NYC - seeking monitoring exp!

Kelly Clinical Research Staffing (Division of Kelly Scientific Resources) is seeking an experienced Regional CRA (Clinical Research Associate) for a contract assignment with a major Pharmaceutical company. The incumbent in this role will be responsible for monitoring studies in and around the NYC metro. All candidates for this position must live in the NYC metro.Job Duties: Oncology Monitoring experienced candidates. Delivery of high quality data according to agreed timelines and budget, ensuring adherence to international and local regulations and corporate SOP standards. Demonstrate exceptional customer focus as evidenced by positive feedback from corporate colleagues and external customers (Investigators). Participate in the site nomination process; perform evaluation of site capability to deliver the contractually agreed to number of patients and high quality data then make recommendation for inclusion in the clinical trial. Assume ambassadorial role to facilitate communication between sites and corporate line functions to increase value proposition to investigators. Facilitate preparation and collection of site level documents. Execute site initiation and training activities. Perform monitoring visits according to monitoring plan and author study monitoring reports. Manage site drug supply management. Resolve site level update of technical systems (ClinAdmin, EDC). Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc). Manage recruitment implementing appropriate contingency plans as needed. Assure continual GCP, ICH and corporate SOP compliance (Informed consent process, source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training. Perform data query resolution process (both at Site and with Data Management). Execute site closeout activities. May act as local (or global) CRA Lead, as assigned. May act as a mentor to new associates for purposes of field training, as assigned. Job Requirements: Experienced Monitors w/Oncology experience. Desired competency in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile. Understands and can apply knowledge of clinical trial designs to trial execution. Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations. Expertise in communication, managing multiple priorities and computer literacy. Education: A Bachelors degree in a scientific or health care discipline preferred. QUALIFIED APPLICANTS ARE ENCOURAGED TO CLICK "APPLY NOW" FOR IMMEDIATE CONSIDERATION!Kelly Scientific Resources®(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research. Learn more about company