Supports the activities of the Principal Investigator in accordance with the protocols and regulations. Involved in the collection, interpretation and documentation of data in support of oncology clinical trials. Manages screening, implements recruitment procedures, consenting, enrollment, randomization and study conduct from planning through study closeout. Perform or implements processes to assure study-related procedures are performed as required and objectives and timelines are met… Show more Supports the activities of the Principal Investigator in accordance with the protocols and regulations. Involved in the collection, interpretation and documentation of data in support of oncology clinical trials. Manages screening, implements recruitment procedures, consenting, enrollment, randomization and study conduct from planning through study closeout. Perform or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. Maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities•Assures compliance with CFR, State regulations, ICH and GCP guidelines and Vanderbilt / VA and sponsors SOPs•Maintains current regulatory documentation according to Essential Regulatory Documents •Perform daily oversight to Electronic Data Capture systems for completeness and resolutions•Assures effective patient identification and recruitment plan is in place•Assures timely reporting of AEs/ SAEs and Protocol Violations•Performs source document verification (SDV) according to contractual requirements•Perform CAPAs •Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit•Provides strong leadership to the team, encouraging innovation and open communication, while implementing procedures•Assures timely completion and submission of CRFs according to Clinical Monitoring Plan and/or Data Management Plan•Provide annual reporting to IRB and prepare annual summaries•Collects and monitor all study patient records to document treatments and outcomes as required by the protocol Show less

Maintain accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities. Coordinates data management activities in support of clinical research studies including pre-entry review, query management, database setup and quality control of the data and project deliverables.

Run experiments for PK/PD (Pharmacokinetic/Pharmacodynamics) and record results In Database. Read and follow protocols, compile and communicate results to supervisor/PI and run data reports. Follow university safety protocols (may include use of combustibles, and/or acids/bases) Enter data involving CDE's and process samples in centrifuge and maintain inventories according to protocols.