The Senior Clinical Research Associate (Sr. CRA) | Monitor plays a critical role in conducting the monitoring for multiple clinical trial sites to ensure high-quality execution and regulatory compliance. This position is responsible for conducting the full range of monitoring visits and ensuring that all assigned sites follow study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. Building strong site relationships is central to this role, supporting effective patient enrollment, data accuracy, and the timely resolution of site-level issues.

QUALIFICATIONS

• Bachelor’s degree in a science/healthcare-related field, or equivalent work experience.
• Minimum 5+ years of direct monitoring experience. Class III medical device and/or cardiovascular trial experience preferred.
• Strong clinical operations background, site management, and/or monitoring experience from study start-up to study close-out without a CRO.
• Excellent organizational, interpersonal, communication, and problem-solving skills.
• Flexibility with changing priorities.
• Ability to efficiently perform and prioritize multiple tasks.
• Extensive knowledge of ICH, ISO, and FDA regulations.
• Experience with Veeva Vault and Medidata RAVE, a plus
• Excellent computer skills, including proficiency in the use of Microsoft Word, Excel, PowerPoint, Smartsheet, and the use of a laptop computer.
• Ability to travel up to 60 – 70%.

• Responsible for conducting the monitoring for multiple clinical trial sites simultaneously.
• Conducts monitoring visits: qualification, initiation, interim, and close-out.
• Develops and reviews monitoring visit reports.
• Ensure compliance with study protocols, GCP, and applicable regulatory requirements across assigned sites.
• Builds strong site relationships to support enrollment data quality and issue resolution.
• Contributes to the development of essential study documents: protocol, informed consent, study plans, etc.
• Ensures site maintains IRB/EC approvals and submits progress reports as required by the IRB/EC.
• Performs study training to new investigators and research coordinators as required.
• Proactively assesses areas for training, efficiency improvements, and other gaps in workflow throughout the trial, both internally (Conformal) and externally (sites).
• Ensures data is entered into eCRFs by investigational sites promptly.
• Supports data management activities such as timely query resolution, data reviews, and identifying or communicating trends.
• Ensures that action items identified during monitoring are closed on time.
• Ensures sites maintain and oversee the investigational product accountability.
• Supports shipping, return, and management of investigational products.
• Ensures the electronic trial master file (eTMF) and investigator site files (ISF) are maintained.
• Ensure clinical sites are audit-ready and support the preparation of internal or external clinical audits.
• Provides site status updates and ensures enrollment and subject retention milestones are met.
• Identifies internal risks, site risks, and compliance problems and escalates when appropriate.
• Maintains current knowledge of applicable US and international clinical regulations, standards, and guidance documents.
• Support the preparation of clinical study reports.
• 60 to 70% travel to support on-site monitoring activities. Travel is preferably regional; however, national travel may be required based on study needs