Senior Clinical Research Associate

This is a fully remote position, open to applicants in California, +3 more states.

📋 Description

• Oversee reliable site relationships and conduct both on-site and remote monitoring activities for Phase I–IV clinical trials.

• Act as the main site manager and initial point of contact between site personnel and Novartis.

• Facilitate collaboration, milestones, and deliverables as a key liaison.

• Monitor compliance with legislation, ICH/GCP guidelines, Novartis standards, monitoring plans, and procedures.

• Execute site initiation visits and provide ongoing training to site staff.

• Carry out continuous on-site and remote monitoring to ensure protocol adherence, GCP compliance, regulatory adherence, process integrity, data integrity, and patient safety.

• Assist in the preparation and gathering of site- and country-level documentation.

• Identify potential risks, address issues, and escalate concerns when necessary.

• Work together with cross-functional teams to enhance study execution and implement process improvements.

• Provide timely, high-quality, and reliable site data that supports Trial Monitoring objectives.

• Collaborate with the SSU CRA to ensure a smooth transition of site responsibilities.

• Serve as a subject matter expert in various study activities when needed.

• Assist in audit and inspection readiness activities, as well as the implementation of corrective actions.

• Propel clinical trials forward at the site level with a focus on patient-centered care.

⛳️ Requirements

• A minimum of 3 years’ experience in site monitoring.

• BS/BA degree in a scientific, healthcare, or related discipline.

• Strong understanding of the drug development process, particularly in clinical trials/research.

• Familiarity with international standards (GCP/ICH, FDA, EMEA).

• Capability to manage multiple priorities and utilize time effectively.

• Exceptional site management skills with proven negotiation and problem-solving abilities.

• Excellent communication and presentation skills, both oral and written.

• Proficient in both written and spoken English.

• Possession of a fully valid and unrestricted driver’s license.

• Willingness to be located in the western region of the United States, preferably near a major airport in California, Washington State, Oregon, or Nevada.

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

🏝️ Benefits

• Performance-based cash incentive.

• Eligibility for annual equity awards, depending on the role level.

• Comprehensive health benefits.

• Life insurance benefits.

• Disability insurance benefits.

• 401(k) plan with company contributions and matching.

• Paid vacation.

• Personal days off.

• Paid holidays.

• Other types of leave.

• Reasonable accommodations for qualified individuals with disabilities.