Senior Clinical Research Associate

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

📋 Description

• Execute and document various types of onsite monitoring visits.

• Participate in study initiation activities (if relevant).

• Conduct CRF assessments, verify source documents, and resolve queries.

• Manage communication and oversight at study sites.

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

• Serve as a contact point for in-house support services and vendors.

• Engage in quality assurance tasks, including compliance monitoring and report evaluations.

• Contribute to feasibility studies.

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

⛳️ Requirements

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

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

• Familiarity with all types of monitoring visits across Phase I-III.

• Previous involvement in clinical projects as a Senior Monitor.

• Required experience in monitoring complex Oncology trials; preference for knowledge of radiopharmaceuticals and/or breast cancer.

• Experience in monitoring gastrointestinal studies (IBD, Crohn's, UC) is preferred.

• Full professional proficiency in English.

• Proficient in MS Office applications.

• Capability to plan, multitask, and thrive in a dynamic team environment.

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

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

• Valid driver's license (if necessary).

🏝️ Benefits

• Health insurance.

• Paid time off.

• Opportunities for professional development.