Clinical Site Manager/Monitor
Allurion Technologies
Natick, MA
03.2023 - Current
- Ensure that all research being conducted complies with the standards and policies of the organization.
- Identify new potential Investigators through ongoing collaborations with internal and external stakeholders.
- Plan, schedule, and conduct various GxP audits throughout all stages of clinical research, which includes project-related, system, supplier, and safety audits.
- Collect and review responses to audit observations and ensure that inadequate or delayed responses are escalated appropriately to meet timelines and obtain satisfactory quality responses.
- Develop Site relationships (incl. Contract Research, Organization issue management, and non-registration/investigator-sponsored research Studies).
- Conducts pre-study visits as appropriate.
- Conduct initiation visits to ensure Investigator and site personnel receive adequate protocol-specific training before site activation.
- Review site activities and quality through on-site and off-site visits.
- Conducts monitoring activities and ensures the safety and protection of study subjects as per the monitoring plan, procedural documents, protocol, ICH/GCP Guidelines, and other local regulations as applicable.
- Collaborate with Risk Management and the Director of Quality to conduct, review, analyze, and summarize findings of audit plans for internal business units and delegated partners.
- Identify opportunities for improvement, prioritize problems, and create performance improvement plans.
- Contribute creative solutions, take ownership of daily assignments, and ensure seamless communication and systematic completion of routine and special projects.
- Work with appropriate teams and departments to manage and plan implementation of patient safety/quality of care initiatives across the organization.
- Ability to use data to assess risks, identify issues, and make appropriate decisions.
- Serve as a point of contact for Sites.
- Provide training to sites.
- Ensure completeness and quality of data submitted from study sites.
- Ensures eCRF data is available and current by using the available systems to follow site activities.
- Oversees activities of site personnel over whom there is no direct authority.
- Motivate/influence sites to meet study objectives, including enrolment and retention goals.
- Demonstrate flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method.
- Anticipate, identify and proactively supports the site in resolving issues as they occur.
- Appropriately document and promptly escalates severe or outstanding persistent problems to the Sr. VP, Clinical Development.
- Initiate, recommend, document, and communicate corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented.
- Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
- Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional, and objective manner.
- Support ensuring access to eDC and vendor systems for clinical trial site personnel.
- Support equipment calibration and tracking.
- Support coordination and ensure local database lock timelines are met as required.
- Proactively identify and resolve potential problems at both site and country level.
- Engage with the Clinical VP, Clinical Development to assist in resolving more complex issues.
- Contribute significantly to the study team and coach site staff to enhance site and hub performance.
- Serve as a critical resource for colleagues by providing 21 CFR/ISO guidance, leading training, and mentoring to other team members through a mentoring process using informal and formal presentations.
