Job Summary
The Lead Clinical Research Associate plays a crucial role in overseeing clinical trials from their inception to completion. This position involves coordinating various aspects of the research process, ensuring compliance with regulatory standards, and fostering collaboration among team members to achieve research objectives. The Lead CRA will facilitate communication between stakeholders while ensuring the integrity and accuracy of clinical data.
Responsibilities
- Oversee and manage clinical trial protocols and developments.
- Monitor study progress and ensure adherence to regulatory guidelines.
- Act as a point of contact for sponsors, clinical teams, and regulatory authorities.
- Lead site selection, initiation, monitoring, and close-out activities.
- Ensure accurate documentation and data quality throughout the study lifecycle.
- Provide training and guidance to junior CRAs and site personnel.
- Prepare and review study reports and presentations for various stakeholders.
- Identify and address issues that may arise during the trial process.
Qualifications
- Bachelor’s degree in life sciences, nursing, or a related field.
- Proven experience in clinical research, particularly in a leadership role.
- Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
- Excellent organizational and multitasking skills.
- Effective communication and interpersonal abilities.
- Experience with electronic data capture and trial management systems.
- Ability to analyze and interpret research data accurately.
