Lead CRA

Job Title: Clinical Study Supervisor

We are seeking a dedicated Clinical Study Supervisor to oversee and supervise clinical studies within the medical device or regulated industry. The role involves ensuring compliance, coordinating with stakeholders, and supporting study activities.

Responsibilities:

1. Organize and supervise clinical study activities, providing oversight on protocol compliance, enrollment, data quality, and monitoring deviations.
2. Assist with clinical monitoring activities as required.
3. Serve as the key contact for assigned clinical sites, ensuring achievement of clinical milestones.
4. Support interactions with Ethics Committees and Competent Authorities.
5. Participate in project team meetings and collaborate with internal stakeholders for proper project conduct.
6. Provide training to site and personnel on study documents, forms, and assessments.
7. Report on site enrollment, device accountability, and protocol deviations.
8. Manage adverse events, document procedural observations, and handle data review, safety reporting, and complaints.
9. Ensure regulatory and protocol compliance, including documentation and timely reporting of adverse events and device issues.
10. Develop and implement improved processes and deliver training on GCPs, protocols, and compliance requirements.
11. Maintain audit readiness and mentor new or junior employees.
12. Perform other duties as assigned by management.

Education and Experience:

• Bachelor's Degree in a related field with 5 years of relevant experience, or
• Associate's Degree or equivalent with 7 years of field monitoring, quality assurance, and regulatory compliance experience.

Additional Skills:

• Proficiency in MS Office Suite and general office machinery.
• Strong communication, presentation, and interpersonal skills.
• Excellent problem-solving and critical thinking abilities.
• Adherence to company rules, safety protocols, and environmental regulations.