Freelance CRA - 1.0 FTE

• May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities. 

• Support development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements.  

• Responsible for source document and case report forms review for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.  

• Managing, preparing, sending, tracking, and returning investigational supplies as assigned. Includes 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.  

• Responsible for review and oversight of regulatory documentations for accuracy, completeness, and supporting assigned clinical sites with any regulatory concerns as appropriate.  

• Responsible for consistent and timely communication 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.  

• Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial. 

Necessary Skills and Abilities: 

• 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. 

• Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision. 

• Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals. 

• Must have a general understanding of routine project goals from an organizational perspective. 

• Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential. 

Educational Requirements: 

• Bachelor's degree or equivalent combination of education and experience. 

Experience Requirements: 

• 3 years+ of experience as a Clinical Research Associate.