Clinical Research Associate

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

📋 Description

• Perform site monitoring visits (initiation, routine, and close-out) to ensure adherence to clinical protocols, GCP, and regulatory standards.

• Aid in the preparation and evaluation of essential trial documents, including informed consent forms, case report forms, and investigator brochures.

• Partner with site personnel to guarantee accurate documentation, prompt data entry, and the resolution of data inquiries.

• Assist in the identification, selection, and training of research sites.

• Maintain precise and complete study files and records in compliance with GCP and company SOPs.

• Oversee study progress to ensure that timelines and quality benchmarks are achieved.

• Report site activities and findings to the Clinical Study Manager and escalate issues as needed.

• Support regulatory submissions by preparing clinical trial applications and keeping relevant documentation up to date.

• Collaborate effectively with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Project Management, to accomplish study goals.

⛳️ Requirements

• Bachelor's degree in life sciences, nursing, or a related discipline.

• At least 4 years of experience in clinical affairs within the pharmaceutical or medical device sectors.

• Familiarity with GCP, FDA/ICH guidelines, and clinical trial monitoring methodologies.

• Strong organizational and problem-solving abilities.

• Exceptional communication and interpersonal skills, with the capability to foster strong relationships with investigative sites and internal teams.

• Proficiency in Microsoft Office and electronic data capture (EDC) systems.

• Willingness to travel up to 50-75% domestically, as necessary.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance plans to ensure you and your family remain healthy and content, with a variety of plan and coverage options.

• Generous paid time off, including holidays, vacation days, and personal leave.

• Annual Bonus opportunity.

• Stock options, providing you with a stake in the company’s future.