Clinical Trial Nurse - Gilbert, AZ

Clinical Trial Nurse - Gilbert, AZ page is loaded## Clinical Trial Nurse - Gilbert, AZ locations:
Gilbert, AZtime type:
Part time posted on:
Posted 30+ Days Agojob requisition :
R1510046
** Job Overview:
Part time - 8 hours/month and onsite support.
** Coordinate and participate in clinical research studies ensuring that studies are carried out according to protocol, contracted scope of work, good clinical practice, sponsor standard operating procedures (SOPs) and any relevant local guidelines and regulations.
** Essential Functions*
* • Provides clinical research support to investigators to prepare for and execute assigned research studies  
• Reviews study protocols, source document forms, other study-specific documents, and electronic data  capture systems used to record clinical research data  
• Collects and submits regulatory/ethics documentation as required by the Federal Drug Administration  (FDA) and other regulatory bodies governing the conduct of the study  
• Recruits and screens patients for clinical trials and maintain subject screening and enrollment logs  
• Orients research subjects to the study including the purpose of the study, procedures and protocol  requirements such as timeline for visits  
• Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice  (GCP)/International Conference on Harmonization (ICH) documentation principles  
• Schedules and executes study visits and perform study procedures as delegated and supervised by the  Principal Investigator  
• Handles lab testing and analysis including preparation of specimen collection tubes and lab logistics  
• Monitors subject safety and report adverse events and reactions to Principal Investigator, study team  members and IRBs as appropriate  
• Corresponds with research subjects to troubleshoot study-related questions or concerns  
• Participates in routine meetings with site study staff and Investigators to confirm study tasks are assigned  and are executed to the expected standards  
• Actively involved in study data quality checking and query resolution  
• Performs a variety of complex clinical research procedures including but not limited to electrocardiogram  (ECG), lab sample collection, spirometry, vital signs, dose verifications, cardiac telemetry monitoring, and  questionnaire administration  
• Updates and maintains site staff skills, training and knowledge of current best nursing practices and topics  related to clinical research  
• Assists the investigators to safeguard the well-being of subjects and maintain standards required of  clinical research sites  
• Maintains a safe environment in accordance with site policies  
• Acts as an advocate for research subjects  
• Addresses subject questions in a pro-active manner and take remedial action as required  
• Assists and advise site staff in nursing practices and on the delivery of study care to subjects  
• Reports any deviations from normal research practices to senior staff and implement agreed changes in  the study care program  
• Assists investigator in verifying that research study objectives are met on time, within budget and  according to application protocol requirements, clinical research regulations and quality standards  
• Assists in providing training to new investigator site staff members on study-specific topics and  requirements  
• Maintains adherence to investigator site staff training requirements by auditing and maintaining training  records  
• Provides guidance and supervision to lower level site staff to help provide that processes are carried out  in line with protocols and SOP's, where applicable  
• Participates in study process reviews and enhancement efforts to support control of site unit budget,  development of the research facilities and site services and the culture towards a high performing research  study team  
• Prepares for and attend study monitoring visits, study audits and regulatory inspections with clinical  research regulatory agencies  
• Adheres to standard operating procedures (SOPs) and other directives throughout this process  
• Assists research site with coverage planning related to staffing…