Job Summary
The Senior Clinical Research Associate (CRA) plays a pivotal role in overseeing and directing clinical trials, ensuring compliance with regulatory requirements and protocols. This position demands a high level of expertise in managing clinical study activities, coordinating with cross-functional teams, and leading monitoring visits to maintain data integrity and participant safety.
Responsibilities
- Lead and manage the planning and execution of clinical trials to ensure adherence to protocols and standards.
- Conduct monitoring visits and provide guidance to study sites, ensuring compliance with regulatory and organizational policies.
- Collaborate with clinical team members, including investigators and sites, to ensure recruitment targets and timelines are met.
- Review and evaluate clinical data, identifying issues and ensuring timely resolution.
- Participate in the development of study-related materials, including monitoring plans and trial master files.
- Facilitate training and mentorship for junior staff and study site personnel.
Qualifications
- Bachelor’s degree in a relevant scientific discipline; a Master’s degree or higher is preferred.
- A minimum of 5 years of experience in clinical research, specifically in monitoring clinical trials.
- Comprehensive knowledge of Good Clinical Practice (GCP) and regulatory requirements.
- Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
- Excellent communication and interpersonal skills to foster relationships with study teams and stakeholders.
- Proficiency in using clinical trial management systems and electronic data capture tools.
