Clinical Research Coordinator

Benefits

Qualifications

• •Excellent organizational and communication skills both verbal and written

Responsibilities

• •The Clinical Research Coordinator must be organized and willing to work a problem to its successful completion
• •Performance Objectives:Represents AICR in a professional and courteous manner (verbal, written and in appearance) when interacting with AICR staff, sponsors, IRBs, and subjects
• •Must be moral and ethical in decision making and during interaction with patients, sponsor and IRB representatives, physicians and other staff
• •Maintains ongoing communication with Director of Research, Associate Director of Research, Principal Investigator/Sub-Investigator, other study personnel and sponsor/CRO per AICR SOPs and as deemed necessary
• •Possesses a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process
• •Maintains confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements with AICR, between AICR and sponsors, and between AICR and other entities.Is creative and diligent in the recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor's timeline while following all policies and regulations governing medical ethics, IRB requirements, federal regulations/ICH guidelines, GCPs and AICR’s SOPs
• •Has training certificate in, and competently perform, pediatric/adult phlebotomy
• •Obtains blood and urine samples and then processes and ships specimens as required
• •Able to accomplish protocol specified patient visits and procedures
• •Clearly and concisely documents patient assessments, observations, test results and other study related information per federal regulations/ICH guidelines, GCPs, AICRSOPs, sponsor/CRO and IRB requirements
• •Maintains accurate and complete written source documentation of patient visits and protocol related activities
• •Accurately completes CRFs/eCRFs and/or worksheets generated by the sponsor/CRO within 1 to 3 business days of the subject’s visit
• •Maintains subject screening logs and protocol deviation logs
• •Responds to monitor notes and/or emails in a timely manner
• •Accounts for clinical trial materials (i.e
• •CRFs, study drug, lab supplies, and/or other required items) and ensures availability of appropriate amounts for the conduct of the study
• •Attends required training courses/conferences in order to stay abreast of current and changing federal regulations and AICR policies
• •Attends Investigator Meetings as directed
• •Performs all duties in a safe and prudent manner
• •Promptly reports adverse events to Associate Director of Research, Principal
• •Other duties as assigned
• •18 more items(s)