Clinical Research Manager
3 days ago
Job Summary
We are seeking a highly skilled Clinical Research Manager to join our team at Genabio Diagnostics. As a Clinical Research Manager, you will be responsible for overseeing and performing clinical monitoring and site management in accordance with ICH Good Clinical Practices, FDA guidelines, ISO standards, local regulations, and Genabio's SOPs.
Key Responsibilities
- Conduct site qualification, initiation, interim monitoring, and close-out visits to ensure compliance with regulatory requirements.
- Document results of visits in monitoring reports for review and finalization, ensuring accuracy and attention to detail.
- Facilitate IRB submissions and renewals as needed, maintaining open communication with research site personnel.
- Collect and review trial master documentation, ensuring compliance with standard processes and policies.
- Motivate investigational sites to close queries and action items, promoting a collaborative and efficient working relationship.
- Maintain contact with research site personnel over the life of a trial, including staffing changes and handling training or retraining.
- Contribute to study plans, site trackers, reports, and routine meetings, ensuring timely and effective communication.
- Ensure consistent use of study tools and training materials, promoting compliance with standard processes, policies, and procedures.
- Assist Quality Assurance with SOP revisions, audits, and inspections, maintaining a high level of quality and compliance.
Requirements
- A Bachelor's degree or equivalent in a life sciences, nursing, or related discipline.
- Minimum 5 years of clinical research experience for medical device and IVD products, with a strong understanding of ICH GCP, FDA, and ISO regulatory guidance.
- Excellent professional written and verbal communication skills, with the ability to write and modify SOPs, work instructions, forms, and templates.
- Excellent time management skills and attention to detail, with the ability to prioritize tasks and manage multiple projects simultaneously.
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