Senior Clinical Research Associate

About the role

Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.

Responsibilities

• Evaluation, site initiation, interim and close out monitoring visits
• Making and sending of monitoring reports within required SOP and local regulatory parameters
• Support development of study specific documentation related to monitoring activities as assigned
• Site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements
• Reviewing and resolving data issues related to source documents and case report forms
• Managing, preparing, tracking, and returning investigational supplies as assigned
• Monitoring and documenting investigational supplies dispensing, inventory, and reconciliation
• Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities, and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements
• Reviewing and overseeing regulatory documentations for accuracy and completeness and supporting assigned clinical sites with any regulatory concerns as appropriate
• Communicating with assigned clinical sites, investigators, site personnel, client personnel, and any other cross-functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities as assigned
• Participating in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial

Requirements

• Excellent verbal, written communication skills and interpersonal and presentation skills are required.
• Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required.
• Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required.
• Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Ability to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
• Ability to offer solutions when obstacles are identified and train as necessary to achieve project goals.
• Strong organizational skills and attention to details required.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• 5+ years of experience as a Clinical Research Associate.