This Senior Site Monitoring position is similar to a Senior Clinical Research Associate role (please read the job description below for more information). We are looking for someone in the Boston, MA area to travel mostly in the local area with the possibility to travel regionally (approx. regional travel up to 20%) if necessary.
• Serve as the site facing role for clinical operations at sites within a region.
• Expedites the pre-study and study initiation processes including conduct of Pre-Study Evaluation and Site Initiation Visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
• Identified, evaluates and recommends potential investigators/sites on an on-going basis within assigned region.
• Critically reviews and analyzes site activities through targeted risk based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable BMS SOPS, subject protection and ICH and/or FDA GCP Guidelines and other local regulations. This includes but is not limited to: Managed multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and or/geographic territory. Significant travel outside of region is rare.
• Ensures timely entry and quality of data submitted from study sites.
• Supervises overall activities of site personnel over whom there is no direct authority and motivates and influences site personnel to meet study and timeline objectives.
• Anticipates and proactively resolves study site issues as they occur. This includes the ability to conduct root cause analysis, implementing corrective actions, ensuring appropriate preventative actions are developed, implemented and being followed and finally the ability to demonstrate via verbal and written methods the process or “story” of the issue.
• Ensures documented follow-up to all outstanding issues within monitoring management system ensuring appropriate issue escalation to line manager and project team members as necessary.
• Facilitates, as needed, internal regulatory compliance audits and Health Authority inspections for assigned sites.
• Provides monitoring assistance to site monitor colleagues within and outside of region to ensure timely execution of deliverables.
• As a Sr. Site Monitor, serves as the example of professionalism, collaboration and efficient execution of deliverables, including mentoring others.
• Proactively communicates and escalates with all internal and external stakeholders any significant issues identified at study sites while developing corresponding mitigation strategies and solutions.
• Prepares and submits monitoring and management reports in a timely, accurate, concise and objective manner.
• Initiates, develops and grows professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders.
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