Essential Duties and Responsibilities: * Coordination and management of clinical trial sites * Monitor via on site visits and via remote review of data collected: if the protocol is adhered to, if the study is performed in compliance with GCP, checks if IRB approvals are still valid and in place * Review in time the eCRF data collection system on completeness and timely query resolution and closure * Site management: build and maintain good relations with investigators and site staff * Ensure that patient enrolment on site follows agreed recruitment plan * Close down study centers on completion of the trial * Ensure that study staff conducting the protocol has received the proper materials and instructions to enter patients into the study * Ensure that the rights, well-being, and safety of human subjects are protected by verifying that informed consent procedures and protocol requirements are adhered to according to regulatory requirements * Ensure data is submitted on Case Report Forms (CRFs) or other data collection tools * Monitor data for missing or implausible data * Maintain proper documentation of all site correspondence * Assist in the training and mentoring of personnel * Contact and troubleshoots non enrolling sites * Perform monitoring and performs clinical closeouts in one or more programs * Performs other related duties as required or assigned Education / Experience Required: * Bachelor's degree in Life Sciences (e.g., Biology, Nursing, Pharmacology) * 2 + years site monitoring experience * 3 + years experience working in Oncology (as a monitor, coordinator, or nurse) * In-depth experience with each stage of a clinical trial (i.e. study start-up through archive) and study site management * In-depth experience with each type of site monitoring visit (pre-study, initiation, interim, close-out) * Thorough knowledge of FDA GCP-ICH Guidelines and local regulatory requirements * Sound knowledge of medical terminology and clinical monitoring process * Excellent verbal and written communications skills * Excellent interpersonal and organizational skills and attention to detail * Computer literacy, proficiency in MS Office * Able to travel up to 50%
To find out more about Real please visit
www.realstaffing.com [1]
Links:
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[1]
http://www.realstaffing.com 