Sr. Clinical Research Monitor - Hybrid/Remote

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The Office of the Vice Provost for Research & Scholarship, Clinical Research Management & Support Office (CRMSO) has an exciting job opportunity for a Sr. Clinical Research Monitor.

CORE JOB SUMMARY              

The Senior Clinical Research Monitor establishes, manages, and meets the milestones of assigned clinical studies in compliance with applicable clinical and regulatory standards related to human subject protocols. 

DEPARTMENT SPECIFIC FUNCTIONS                                                                          

• Manages all study parameters, clinical study start-up activities, enrollment, and data collection.
• Assists and/or leads efforts in protocol feasibility analysis, site identification, and patient recruitment and planning.
• Independently performs centralized monitoring and on-site monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits.
• Performs on site visits and source data verification of eCRFs/EDC as stipulated.
• Establishes and maintains regular contact with investigators, vendors, and study sites to ensure FDA/ICH-GCP/protocol compliance, and assessment of accrual rates.
• Performs drug accountability based on review of drug/device disposition records.
• Prepares clinical monitoring plans and source document templates.
• Assists in study start-up activity including site selection and review of regulatory documents and ensures site is qualified to conduct the study.
• Documents monitoring activities in monitoring reports and follow-up letters.
• Communicates non-compliance issues to the Principal Investigator and appropriate team member(s) in a timeline manner.
• Escalates non-compliance issues as per applicable SOP.
• Communicates project-specific information to/from trial sites and documents communication with study site/ team.
• Collaborates with Clinical Trials Unit Team and others to collect data/documents from sites within established timelines.
• Ensure the reporting of high quality data and timely query resolution.
• Reviews adverse event reports and ensures the site is reporting the events appropriately and in a timely manner.
• Provides full support to CRO (as applicable) and investigative sites to facilitate study conduct.
• Maintains ICH-GCP documentation for trial sites as applicable.
• Presents at and participates in Investigator Meetings, other study trainings and meetings as required.
• Takes an active role in project team activities including monitoring report review and tracking.

CORE JOB FUNCTIONS                                                                                           

• Oversees clinical study sites to assure activities are in adherence with Good Clinical Practices (GCPs), federal regulations, standard operating procedures, and study protocols.
• Reviews regulatory documents and prepares site visit reports.
• Assists with study development and start-up processes, including reviewing protocols, and preparing informed consent forms.
• Participates in clinical training programs and maintains awareness of developments in the field.
• Evaluates quality and completeness of data and participants’ safety documentation.
• Provides consultation on quality control and assurance issues to research sites and investigators.
• Generates monitoring reports of findings, and tracks correction efforts.
• Assists the preparation and presentation of educational programs to the University’s research community.
• Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research.
• Interacts with other departments and external entities to resolve research-related problems.
• Helps with the creation and maintenance of policy and procedure manuals intended to assist University researchers in maintaining compliance with research standards and guidelines.
• Provides regulatory support to principal investigators and research teams. Provides assistance in the maintenance of a corrective action preventive action system.
• Maintains databases, and electronic and paper audit files. Assists with internal and ex