What are the responsibilities and job description for the CENTRAL MONITOR position at Technical Resources International, Inc.?
Job Description
- Creation and ownership of risk-based quality management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials.
- Review protocols to ensure the set-up, review, and reporting requirements for KRIs and QTLs can be met and are standardized.
- Provide input and lead the study risk assessment, and propose appropriate protocol-specific risk indicators for centralized monitoring.
- Support setup and testing of centralized monitoring data analysis platform.
- Review clinical study data and make independent decisions to identify potential site performance and site organization issues, and make appropriate recommendations to CRAs for investigation and targeted activities.
- Train and support the project teams on interpretation of central monitoring signals and relevant decision making for study conduct.
- Manage operational risk log for Clinical Risk Management activities.
- Provide mentorship, guidance/training, and coordination for all central monitoring activities.
- Perform central monitoring activities including review of system dashboards and outputs, propose suggestions for signal and action management, and follow up with study team for action resolutions.
- Serve as Central Monitoring Subject Matter Expert (SME) during the development, implementation, and execution of central monitoring dashboards.
- Operate in a client-facing role to advise clients and study sponsors on industry-standard best practices for conducting centralized monitoring.
- Communicate effectively with cross-functional teams of CRAs, Clinical Project Managers, Clinical Trial Managers, and Data Management & Data Analytics staff.
- Applies a thorough understanding of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and statistical requirements in the conduct of central monitoring.
- Supports one or more government or commercial contracts in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse.
- Informs division leadership on the overall status of clinical programs/projects and of potential issues/mitigation.
- Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays.
- Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
- Support and comply with the company’s Quality Management System policies and procedures.
- Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development, participation in proposal writing, budget development, and bid defense meetings.
- Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up.
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring.
- Minimum of 3 years relevant experience with central monitoring in a CRO setting
- Prior experience as a CRA conducting on-site monitoring, or relevant skillset
- Knowledge of central monitoring database technologies and processes
- Experience managing or mentoring central monitoring teams, writing procedures, and advising on central monitoring best practices and tools.
- Strong facilitation, presentation, problem-solving, and conflict resolution skills; including ability to keep up with changing priorities, seasoned oral and written communications skills, strong attention to detail with ability to QC information, and experience in the use and development of clinical research databases/ systems/ tools.
- Background in Infectious Disease clinical trials and/or Oncology; or, prior work on a government contract, is a plus.
- This role is fully remote to those in/willing to relocate to Maryland, Virginia, or Washington D.C.