Clinical Trials Supervisor
2 weeks ago
Position Overview
The Clinical Research Manager is responsible for overseeing and executing clinical monitoring and site management in compliance with ICH Good Clinical Practices, FDA regulations, ISO standards, local laws, and Genabio Diagnostics' standard operating procedures (SOPs). This role is pivotal in fostering collaborative relationships with investigational sites and collaborating closely with project management and regulatory teams to identify and address risks related to patient safety and data integrity.
Key Responsibilities
- Conduct site qualification, initiation, interim monitoring, and close-out visits.
- Document visit outcomes in monitoring reports for review and finalization.
- Facilitate Institutional Review Board (IRB) submissions and renewals as necessary.
- Collect and review essential trial master documentation.
- Encourage investigational sites to resolve queries and action items promptly.
- Maintain ongoing communication with research site personnel throughout the trial duration, including managing staffing changes and providing necessary training or retraining.
- Contribute to the development of study plans, site trackers, reports, and participate in routine meetings.
- Ensure the consistent application of study tools and training materials while adhering to established processes, policies, and procedures.
- Assist Quality Assurance with revisions of SOPs, audits, and inspections.
- Perform additional tasks as assigned that are not explicitly described.
Qualifications
- A Bachelor's degree or equivalent in life sciences, nursing, or a related field.
- A minimum of 5 years of experience in clinical research, specifically for medical device and in vitro diagnostic (IVD) products.
- Alternatively, a combination of education, training, and experience in a life science environment with involvement in clinical trials may be considered.
Skills and Competencies
- Commitment to continuous learning and training on ICH GCP, FDA, and ISO regulatory guidelines.
- Exceptional written and verbal communication skills.
- Strong time management abilities and meticulous attention to detail.
- Capability to draft and revise SOPs, work instructions, forms, and templates.
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