Clinical Research Associate Job in Raritan 08869, New Jersey US
Clinical Research Associate III (CRA III)
The senior CTS position supports complex clinical trial activites. Partners with CTM/CPM to ensure site related start up through close out activites are conducted as per GCP, and regulatory requirements. Vendor oversight and management is required and identifies issues in a timely manner and escalates to management as appropriate. Will complete monitor trip report review, site audit reports and monitors on site to assess for quality, GCP and regulatory compliance. Monitors clinical studies for adherance to protocol, ICH/GCP, SOP's and follows Clinical Monitoring Plan ie on site quality visits, review approve trip reports, monitor metrics of vendor/site performance. Ensures quality of data generated from clinical sites and assits in resolving subject eligibility/protocol deviations issues and confirms accuracy of clinical data. Works closely with CTM and Data Managment lead to develop data quality plans and processes. Ensures safety issues are reported to GPRM and follow up issues are closed within expected timeframe. Will prepare sections of protocol and amendments, and ICF's. Develops and maintains guidance and process instruction documents, maintain study documents (consent templates, site procedural instructions etc) Resonsibility to ensure site enrollment metrics are closely tracked to identify risk and elevate as appropriate to support enrollment goals. The tracking of essential documents are received /approved filed for the duration of the study. Reviews/approves site ICF's for continuity and follow up with functional leads as appropriate . Works with Data Management in the creation and execution of Data Management Plan. Works with CTM to coordinate activities from third party vendors, monitors metrics and study status (accruals and atrition), query tracking, non compliance protocol deviations. Responsible for the operational execution of a study under the direction and supervision of the Director ie protocol planning, study execution and implementation through data base lock. Manages department teams or task forces to improve Janssen AI processes for trial execution. May be responsible for SOP review and development. Maintains expertise through familiarity with clinical scientific literature and professional activites. Data cleaning, complete specific sections for annual IND safety updates, involved with protocol development and amendments, manage the resolution of GCP site audit reports, a resource for other team members ie on board training, particiate in investigator meeting planning and presentation.,
Please respond by sending over a copy of your resume to garima@ustechsolutions.com