Senior Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary point of communication with project stakeholders.

• Ensure that timelines, objectives, and standards for clinical research projects are met.

• Develop and nurture relationships with clinical sites and investigators.

• Conduct and document various types of onsite monitoring visits.

• Engage in study startup activities when necessary.

• Execute CRF reviews, source document verifications, and resolve queries.

• Oversee site communication and manage site-related activities.

• Supervise study operations, timelines, and schedules at the country level.

• Coordinate with in-house support services and vendors as needed.

• Participate in quality control activities, including compliance monitoring and report evaluations.

• Take part in feasibility research initiatives.

• Assist the regulatory team in preparing documentation for study submissions.

• Ensure the rights, safety, well-being of subjects, and compliance with data quality standards.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a comparable combination of education, training, and experience.

• At least 5 years of independent on-site monitoring experience in the USA.

• Experience with all types of monitoring visits in Phase I–III clinical trials.

• Involvement in clinical projects as a Senior Monitor.

• Required experience in monitoring complex oncology trials.

• Preferred experience with radiopharmaceuticals and/or breast cancer studies.

• Preferred experience in monitoring gastrointestinal studies (IBD, Crohn’s, UC).

• Full working proficiency in English is essential.

• Competence in MS Office applications is required.

• Ability to plan, manage multiple tasks, and thrive in a dynamic team environment.

• Strong communication, collaboration, and problem-solving skills.

• Willingness to travel up to 80% of the time.

• Valid driver's license, if relevant.

• Must not require a work visa for initial or continued employment now or in the future.

🏝️ Benefits

• Employees have the option to work remotely.

• Opportunities for career advancement are available.

• Engage in hands-on involvement in all aspects of the study.

• Chance to lead challenging full-service projects at the country or regional level.

• Work for a company that prioritizes its employees.