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Senior Clinical Research Associate
hace 2 meses
The Senior Clinical Research Associate plays a pivotal role in overseeing and coordinating all facets of clinical monitoring and site management in compliance with ICH GCP, FDA regulations, local laws, and Thermo Fisher Scientific's standard operating procedures.
Key Responsibilities:- Conduct site visits to evaluate adherence to protocols and regulatory standards while managing necessary documentation.
- Ensure data integrity and compliance to withstand international quality assurance audits.
- Foster and maintain collaborative relationships with investigational sites and client personnel.
- Assist project managers or clinical team leaders on designated projects, with travel requirements typically ranging from 60-80%.
- Monitor investigator sites to validate the accuracy of case report form entries against patient records.
- Perform physical inventory checks and review records related to investigational products.
- Document findings in reports and correspondence promptly, adhering to approved business writing standards.
- Proactively escalate identified deficiencies to clinical management, offering potential solutions and ensuring resolution.
- Maintain ongoing communication with investigative sites between monitoring visits to confirm protocol adherence and timely data recording.
- Provide status updates and progress reports to the Clinical Team Manager as required.
- Participate in investigator meetings and collaborate with clients to identify potential investigators.
- Initiate clinical trial sites in accordance with established procedures, ensuring compliance with protocols and regulatory obligations.
- Contribute to project teams by assisting in the preparation of publications and sharing insights with colleagues.
- Manage essential documents throughout the clinical trial lifecycle in accordance with local regulations and ICH GCP.
- Facilitate effective communication among investigative sites, clients, and the Thermo Fisher Scientific project team.
- Respond to audits and regulatory requirements from clients and federal entities.
- Complete administrative tasks, including expense reports and timesheets, in a timely manner.
Engage in other project-related tasks as assigned, ensuring a comprehensive approach to clinical trial management.
