Senior Clinical Research Associate

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

📋 Description

• Conduct and supervise site visits, encompassing selection, initiation, interim, and close-out visits.

• Collaborate with Principal Investigators, study coordinators, and interdisciplinary teams.

• Ensure adherence to ICH/GCP, IRB standards, and internal monitoring plans.

• Identify and address data collection challenges within electronic data capture (EDC) systems.

• Review and reconcile data queries, listings, and inconsistencies.

• Maintain precise and comprehensive study documentation and records.

• Lead study team meetings and contribute to the development and amendments of protocols.

• Support site recruitment efforts and oversee enrollment objectives.

• Mentor junior Clinical Research Associates (CRAs) and offer technical guidance in clinical programming and data validation.

• Develop and enhance standard operating procedures (SOPs), workflows, and templates.

• Collaborate with the Clinical Trials Manager on timelines, budgets, and resource allocation.

• Act as a liaison with regulatory authorities and Contract Research Organizations (CROs).

• Ensure the prompt and compliant execution of monitoring reports, trip reports, and follow-up correspondence.

• Monitor site performance metrics and facilitate communication among stakeholders.

⛳️ Requirements

• Bachelor’s degree or higher in biomedical sciences or a related field.

• Over 5 years of experience in clinical research within biotechnology, pharmaceuticals, medical devices, or academia.

• Strong understanding of GCP, FDA regulations, and ISO standards.

• Proficient in EDC systems, Clinical Trial Management Systems (CTMS), and Microsoft Office Suite.

• Certification (CCRC or CCRA) is advantageous.

• Excellent grasp of medical terminology and clinical trial processes.

• Demonstrated ability to manage multiple studies and priorities with accuracy and urgency.

• Outstanding communication, organizational, and interpersonal skills.

• Proven ability to work both independently and collaboratively in remote, cross-functional teams.

• Willingness to travel up to 75% of the time.

• A proactive attitude and high standards for quality and precision.

• Strong analytical and problem-solving skills.

• Ability to quickly adapt to shifting demands and environments.

• A customer-centric approach when working with sites and external partners.

• Commitment to continuous improvement and operational excellence.

🏝️ Benefits

• Competitive base salary and performance-based compensation.

• Comprehensive health and welfare benefits, including a gym reimbursement program.

• 401(k) savings plan with matching contributions.

• Employee Stock Purchase Plan.

• Pre-tax commuter benefits.

• Up to 30 days of paid leave annually for full-time employees who donate an organ or bone marrow.

• Additional discretionary bonuses/incentives and restricted stock units may be available.