The Central Monitoring Associate position is responsible for providing support to the clinical monitoring teams while utilizing centralized data and reporting tools in accordance with Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines and study specific plans.

Essential Functions:

• Performs remote site monitoring and management activities for assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and ProPharma Group SOPs and project plans. 

• Supports study monitoring team in implementing study strategies, initiatives, and processes and standards, to ensure consistent, efficient, and quality processes to meet quality, and study delivery within the expected timelines. 

• Supports collection of data, and report generation to support activities such as recruitment plan, and enrollment, drug supply status, site payment status, and any other relevant tracking to support successful clinical trial execution. 

• Supports data risk assessments as assigned. 

• Supports monitoring teams throughout the duration of the study including communication with the clinical site institutions as appropriate. 

• May be required to support any document collection, visit preparation, and study data review and central monitoring activities as assigned. 

• Other duties as assigned. 

Necessary Skills and Abilities:

• Effective communication, and interpersonal skills with ability to partner with cross functional internal and external stakeholders. 

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

• Ability to contribute to the development of tools and processes that increase measured efficiencies of the project. 

• Proficiency in working with systems used in the clinical trial execution such as but not limited to Electronic Document Management Systems, Electronic Data Capture Systems, Clinical Trial Management Systems, etc.  

• Exhibits a good understanding of general quality assurance concepts and practices. 

• Highly organized with a strong attention to detail. 

Educational Requirements:

• Bachelor’s degree preferred. Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration. 

Experience Requirements:

• Minimum 3 years of experience in study coordination and in house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical industries or relevant, regulated environment. 

Experience Desired:

• Working knowledge of Cluepoints RBQM System
• Long-haul COVID/Pulmonary experience

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