Sr. Clinical Research Associate

Philips • Bothell, WA

15d • Onsite

About The Position

Senior Clinical Research Associate, Oral Healthcare The Senior Clinical Research Associate oversees site performance and compliance with safety and regulatory standards, provides guidance with minimal supervision, and drives process improvements for efficient, high-quality clinical research. This role ensures consistent communication of study procedures and the adoption of compliant practices across all Philips research programs involving human participants. Your role: Plan and conduct monitoring of both external and internal oral healthcare studies, ensuring safety, efficacy, and compliance with regulatory standards, both remotely and on-site, as needed. Collaborate with cross-functional teams, including Clinical Development, the R&D Product Research Center, and regional clinical research teams, including sharing of best practices and to address study challenges. Support study managers by executing delegated monitoring and study start-up and management tasks, particularly during periods of increased workload. Act as study manager, when needed, with guidance and oversight. Contribute to study database user acceptance testing (UAT), development of case report forms, and coordination with data management for database development and accountability support. Travel to external clinical trial sites for monitoring, site qualification, initiation, and closure visits. Maintain up-to-date study registrations and compliance within the Clinical Trial Management System (CTMS). Contribute to study audit readiness and support GCP audits.

Requirements

• You’ve acquired 5+ years of experience in clinical research, some medical device research experience required.
• Your skills include knowledge and demonstrate expertise with site execution, activation, and closeout activities
• Knowledge of GCP, ICH, and other relevant clinical research guidelines required.
• You have demonstrated experience with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and remote monitoring systems.
• You have a bachelor’s degree or higher in a relevant science field.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• You’re an excellent communicator with an ability to work well cross functionally, and in a complex global working environment.
• This role requires up to 25% travel to clinical trial sites based on business needs.

Nice To Haves

• Experience with electronic informed consent and remote source document review desired.
• Study planning and site readiness experience preferred.
• Related device expertise preferred.
• CCRA certification preferred but not required.

Responsibilities

• Plan and conduct monitoring of both external and internal oral healthcare studies, ensuring safety, efficacy, and compliance with regulatory standards, both remotely and on-site, as needed.
• Collaborate with cross-functional teams, including Clinical Development, the R&D Product Research Center, and regional clinical research teams, including sharing of best practices and to address study challenges.
• Support study managers by executing delegated monitoring and study start-up and management tasks, particularly during periods of increased workload.
• Act as study manager, when needed, with guidance and oversight.
• Contribute to study database user acceptance testing (UAT), development of case report forms, and coordination with data management for database development and accountability support.
• Travel to external clinical trial sites for monitoring, site qualification, initiation, and closure visits.
• Maintain up-to-date study registrations and compliance within the Clinical Trial Management System (CTMS).
• Contribute to study audit readiness and support GCP audits.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees