The Senior CRA independently manages and monitors clinical trial site activities to ensure compliance with protocols, FDA regulations, and ICH-GCP guidelines. Responsibilities include conducting site visits, managing investigational product inventory, and maintaining audit-ready site files.
The Contract Senior CRA independently manages and monitors clinical trial site activities to ensure compliance with protocols, FDA regulations, and ICH-GCP guidelines. Responsibilities include site qualification, initiation, interim monitoring, and close-out visits, as well as maintaining audit-ready site files.
The Quality Operations Manager supports quality management systems by collaborating with operational teams on study document reviews, CAPA management, and database testing. They also lead audit preparation, facilitate vendor audits, and ensure compliance with FDA regulatory requirements and company SOPs.
The Project Manager is responsible for the overall management, execution, and reporting of clinical study operations, including budgeting and timeline adherence. They act as a liaison between sponsors, internal teams, and clinical sites to ensure regulatory compliance and quality service delivery.
The Project Manager is responsible for the overall management, execution, and reporting of clinical study operations, including budgeting and timeline adherence. They act as a liaison between sponsors, internal teams, and clinical sites to ensure compliance with regulations and project deliverables.
The Clinical Trials Assistant supports clinical operations by managing essential study documents, maintaining the trial master file, and ensuring compliance with regulatory guidelines. They also assist with study drug release, investigator meeting planning, and tracking clinical trial progress.
The TMF Specialist manages, reviews, and approves site-level documentation within the electronic Trial Master File to ensure audit readiness and study compliance. They collaborate with internal teams to resolve document discrepancies and maintain accurate records throughout the study lifecycle.
