Senior Clinical Research Associate

Philips

24d•$102,000 - $182,000•Onsite

About The Position

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. 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.

Requirements

Minimum of 5+ years' experience in Clinical Research within FDA regulated medical device/product environments
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 high level of competency
Strong understanding of how to review clinical study data and / or monitor study data
Ability to effectively communicate with internal and external stakeholders, ensuring 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
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.

Nice To Haves

Master’s degree desired
SOCRA Certified Clinical Research Professional desired

Responsibilities

Developing comprehensive study plans/protocols
Ensuring adherence to ISO/FDA regulatory requirements, Good Clinical Practice (GCP) guidelines, and study objectives
Supervising study sites and activities to ensure strict adherence to clinical study protocols, regulatory standards (ISO, GCP, FDA), and Philips procedures
Conducting site assessments, on-site and remote monitoring, and close-out visits
Resolving queries, issues, and discrepancies related to study conduct, data collection/integrity, and regulatory compliance
Ensuring efficient organization and accessibility of study-specific materials/documentation
Performing data review and verification activities to ensure accuracy and consistency of clinical trial data
Providing support, training, and guidance to study sites and investigators on protocol requirements, study procedures, and regulatory expectations
Communicating with internal and external stakeholders to ensure clarity and alignment on project objectives, milestones, and timelines
Escalating significant issues and deviations to study leadership/appropriate stakeholders
Evaluating site performance and capabilities through comprehensive assessment and analysis
Providing input to study updates, findings, and recommendations to internal and external stakeholders
Monitoring study progress and performance metrics
Driving the development and implementation of innovative process improvements and best practices