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.
ICON provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
