Clinical Site Monitor
Bristol-Myers SquibbBeijingUpdate time: August 25,2019
Job Description
- Identifies, evaluates, and recommends new potential investigators/sites on an on-going basis through medical community networking or internal BMS requests, to assist in the placement of planned clinical studies with qualified investigators.
- Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts Site Initiation visits in collaboration with RCO Site Managers and/or CCO Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
- Reviews site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable BMS SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes, but is not limited to:
- Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Ensures quality of data submitted from study sites and assures timely submission of data.
- Ensures safety and protection of study subjects according to the monitoring plan, BMS SOPs, and ICH and/or FDA GCP Guidelines.
- Manages overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives.
- Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed. Ensures documented
- Facilitates the Regulatory Compliance audit process, as needed.
- Provides monitoring assistance to site monitor colleagues, as requested.
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, tactful and objective manner.
- Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist), peers, and BMS office-based personnel. Uses multiple technologies to maintain open and frequent communication with BMS personnel.
- Resolves most study-related issues independently, with management support. Uses functional expertise and exercises good judgment in seeking appropriate counsel and authorization.
- Exhibits high degree of flexibility when facing changes such as program priorities, protocol
- Employs good fiscal management to conserve the costs of departmental operation and controls travel expenses.
- Participates in appropriate professional organizations, meetings, symposia, and continuing education programs to maintain knowledge and expertise across multi-therapeutic areas.
- Participates in departmental/divisional special projects, cross functional work groups, task forces and study feasibilities.
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