Senior Clinical Research Associate

Senior Clinical Research Associate Job Description The Senior Clinical Research Associate is responsible for developing comprehensive study plans/protocols, ensuring adherence to ISO/FDA regulatory requirements, Good Clinical Practice (GCP) guidelines, and study objectives to ensure robust data integrity and study execution. Your Role Provides support to the Clinical Study Manager by supervising study sites and activities to ensure strict adherence to clinical study protocols, regulatory standards (ISO, GCP, FDA), and Philips procedures; this includes conducting site assessments, on‑site and remote monitoring, and close‑out visits, as well as resolving any queries, issues, and discrepancies related to study conduct, data collection/integrity, and regulatory compliance. Ensures efficient organization and accessibility of study‑specific materials/documentation, including protocols, informed consent forms, and study manuals, ensuring compliance with regulatory requirements and GCP guidelines. Enhances study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle, performing data review and verification activities to ensure accuracy and consistency of clinical trial data. Provides support, training, and guidance to study sites and investigators on protocol requirements, study procedures, and regulatory expectations; effectively communicates with internal and external stakeholders to ensure clarity and alignment on project objectives, milestones, and timelines, fostering a collaborative and compliant research environment. Escalates significant issues and deviations to study leadership/appropriate stakeholders, providing thorough analysis, recommendations, and mitigation strategies to facilitate timely resolution and minimize impact on study outcomes. Evaluates site performance and capabilities through comprehensive assessment and analysis, identifying opportunities for improvement and providing targeted support and guidance to enhance site performance and study quality. Provides input to study updates, findings, and recommendations to internal and external stakeholders, including study teams, and management. Monitors study progress and performance metrics, conducting in‑depth analysis of trends and deviations to inform proactive decision‑making, risk mitigation strategies, and continuous improvement initiatives. Drives the development and implementation of innovative process improvements and best practices, leveraging insights from ongoing monitoring and evaluation to enhance the efficiency, quality, and outcomes of clinical research activities. You're the Right Fit If Minimum of 5+ years’ experience in Clinical Research within FDA regulated medical device/product environments, with strong knowledge of ISO14155‑GCP and regulatory requirements (ISO, FDA). Proven experience utilizing clinical trial applications including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with a high level of competency. Strong understanding of how to review clinical study data and/or monitor study data. Effective communication skills with internal and external stakeholders to ensure clarity and alignment on project objectives, milestones, and timelines. Proven experience in clinical site assessments, developing comprehensive study plans/protocols, on‑site/remote monitoring, close‑out visits, and providing clinical support, training, and guidance to study sites and investigators. Ability to conduct in‑depth analysis of performance metrics—trends and deviations—to inform proactive decision‑making, risk mitigation strategies, and continuous improvement initiatives. Minimum of a Bachelor’s Degree in Life Sciences or comparable disciplines. Master’s degree desired. SOCRA Certified Clinical Research Professional desired. Location This is a Field role. Prefer candidates reside within commuting distance to Plymouth, MN. Salary & Benefits The pay range for this position varies by state. AL, AZ, AR, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MI, MS, MO, MN, NC, ND, NE, NH, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV or WY: $102,000‑$162,000 AK, DE, HI, MD, MN, RI: $107,000 to $170,000 CA, CT, DC, MA, NJ, NY or WA: $114,000 to $182,000 Employees are eligible for a comprehensive benefits program, including PTO, 401(k) with up to 7% match, HSA, stock purchase plan, and education reimbursement. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa now or in the future. May travel up to 50%. Equal Employment Opportunity Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. #J-18808-Ljbffr Council of State and Territorial Epidemiologists