Senior Clinical Research Associate – FSP

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

📋 Description

• Oversee and support both in-house and outsourced clinical site monitoring activities to ensure compliance with Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols.

• Work collaboratively with study teams during the start-up/feasibility phase and engage in site identification and assessment tasks.

• Identify underlying issues and proactively escalate and resolve Clinical Research Associate (CRA) and site performance challenges through collaboration with stakeholders.

• Offer monitoring expertise, mentorship, and training to junior team members as needed.

• Foster positive working relationships and actively seek feedback from site teams, including Principal Investigators, Study Coordinators, Pharmacists, and Site Administration.

• Collaborate with study teams and sites on outreach activities related to patient recruitment and retention strategies.

• Contribute to and lead cross-functional teams in defining monitoring strategies, including risk-based monitoring approaches.

• Leverage regional knowledge to adapt study processes and documentation as feasible.

• Represent the Monitoring team at Investigator Meetings when necessary.

• Work with study teams and stakeholders to perform site assessments, pinpoint performance issues, and implement solutions that align with project objectives and operational efficiency.

• Carry out additional tasks as required.

⛳️ Requirements

• Willingness to travel domestically.

• Proven ability to work independently as well as collaboratively within a team environment.

• Proficient in MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint).

• Exceptional oral and written communication skills along with strong organizational capabilities.

• Relevant clinical research experience in biotechnology, pharmaceuticals, Contract Research Organizations (CROs), or medical device industries.

• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.

• Experience in Oncology is preferred.

• A minimum of 5 years of relevant monitoring experience.

• BA/BS, nursing degree, or an advanced degree is required.

• A degree in the life sciences is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits, including medical, dental, and vision coverage.

• Retirement savings plan with employer matching.

• Opportunities for professional development and continuing education.

• Flexible work arrangements and a supportive work environment.