Senior Clinical Research Associate

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

📋 Description

• Conduct and provide reports for various onsite monitoring visits.

• Engage in study startup activities, as required.

• Execute CRF reviews, verify source documents, and resolve queries.

• Oversee communication with study sites.

• Manage study activities, timelines, and schedules at the national level.

• Act as a liaison for in-house support services and vendors.

• Participate in quality control efforts, including compliance monitoring and report assessments.

• Contribute to feasibility studies.

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

• Develop and nurture relationships with clinical sites and investigators.

• Ensure adherence to timelines, targets, standards, and compliance with subjects’ rights, safety, well-being, and data quality.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a comparable mix 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.

• Preferred experience with radiopharmaceuticals and/or breast cancer.

• Preferred familiarity with GI studies (IBD, Crohn's, UC).

• Strong working proficiency in English.

• Competence in using MS Office applications.

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

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

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

• Valid driver’s license (if applicable).

• Must not require a work visa for current or future employment.

🏝️ Benefits

• Remote work options available for employees.

• Full-time employment opportunity.

• Potential for career advancement in clinical research.

• Hands-on participation in all aspects of the study.

• Opportunity to work on challenging full-service projects at the country or regional level.