Sr. Clinical Monitor

About the role

The Sr. Clinical Monitor performs site monitoring and site management activities to assess the progress of projects at assigned investigative/physician sites (either on site or remotely) and ensures clinical studies are conducted, documented, and reported in accordance with the clinical protocol, HRCRS and Sponsor Standard Operating Procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements.

The Sr. Clinical Monitor represents clinical monitoring on assigned Study Teams, under the oversight of the Clinical Operations Manager and the Project Manager and provides operational expertise and functional leadership to project CRA/Monitors performing study activities. This role is also responsible for assessing clinical trial site performance and the effectiveness of monitoring activities through monitoring visit report review and metric tracking; communicating issues, risks and mitigation strategies to the Project Manager and Clinical Operations Manager; and contributing to the development and maintenance of study-level documentation.

What you'll do

• Conducts review of monitoring visit reports and associated visit deliverables; evaluates site compliance, escalates identified noncompliance per project plans, and contributes to corrective and preventative action planning
• Performs tracking activities for monitoring visit scheduling, performance, and completion of monitoring visit deliverables to ensure compliance with project plans and HRCRS SOPs
• Constructs or contributes to the construction of project documentation including the following: project plans, monitoring visit tracking tools, visit reports, and site and/or CRA training materials, additional documentation at the request of Project Management or Clinical Operations Manager
• Assists with CRA/Monitor study coordination, training, and mentoring via co-monitoring activities and meeting conduct
• Performs senior-level monitoring oversight across studies/sites, including site qualification, site initiation, interim monitoring, site management activities and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP, monitoring plan and protocol compliance.
• Provides strategic site management and escalation, proactively identifying site- and study-level risks through analysis of monitoring findings, study metrics, KRIs, and site performance trends; partners with Project Management and cross-functional stakeholders to implement mitigation and corrective/preventive actions aligned with the monitoring plan.
• Proactively identifies site and study-level risks through analysis of monitoring findings, study metrics, and site performance trends and collaborates with Project Management to implement mitigation strategies in alignment with the monitoring plan.
• Conducts risk-based monitoring activities including source data verification review of appropriate site source documents and medical records. Verifies the required clinical data entered in the case report forms are accurate and complete and utilizes query resolution techniques remotely and on-site.
• Verifies site informed consent process is adequately performed/documented for each subject.
• Routinely reviews the Investigator Site File for accuracy, timeliness and completeness.
• Reconcile the ISF with the Trial Master File and collect any outstanding documents.
• Serves as primary point of contact with study site personnel. Documents all activities and communications with the site via confirmation letters, follow-up letters, monitoring visit reports, communication logs and other required project documentation. Follow up on action items to ensure timely completion.
• Trains site staff on protocol, study procedures, EDC and other study specific systems.
• Prepares for and attends Investigator Meetings and sponsors face-to-face meetings.
• Cohorts documentation with site for IRB applications and renewals as needed.
• Completes proper submission of documentation of training, and documentation of hours worked (contractor or hourly employees only)
• Adheres to HRCRS or client SOPs (as applicable), and professionally represents HRCRS in business interactions
• Demonstrates accountability by completing all mandatory training on time and in accordance with company requirements.
• Regular and reliable attendance
• Other duties as assigned

Qualifications

• Bachelor’s degree, ideally within a scientific or healthcare field, a healthcare certification, or an equivalent combination of education, training and experience
• 3-5 years of relevant experience
• Must have a thorough understanding of current ICH-GCP and applicable FDA regulations
• Ability and willingness to travel domestically 60%-80%
• Strong interpersonal skills and ability to forge relationships with clinical sites and colleagues
• Excellent oral and written communication skills, with ability to articulate issues
• Self-management skills, including ability to multi-task
• Attention to detail and accuracy in work
• Well organized, with strong problem solving and time management skills

LOCATION AND TRAVEL REQUIREMENTS

This is a hybrid position and may be performed anywhere within the United States of America. Regular domestic travel will be required for site visits, company meetings, audits, etc.