[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a health technology company dedicated to improving reputed company reputed company for reputed company. They are seeking a Senior Clinical Research Associate who will be responsible for developing study plans, ensuring compliance with regulatory requirements, and supervising clinical study activities to maintain data reputed company and study execution.

Responsibilities

• 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 reputed company procedures; this includes conducting site assessments, on-site and remote monitoring, and reputed company-out visits, as well as resolving any queries, issues, and discrepancies reputed company to study conduct, data collection/reputed company, 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 reputed company stakeholders to ensure reputed company 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 reputed company
• 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 reputed company stakeholders, including study teams, and management
• Monitors study reputed company and performance metrics, conducting in-depth analysis of trends and deviations to inform proactive decision-making, risk mitigation strategies, and reputed company 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 reputed company of clinical research activities

Skills

• Minimum of 5+ years' experience in Clinical Research reputed company 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 (reputed company), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with high level of competency
• Strong understanding how to review clinical study data and/or monitor study data
• Ability to effectively communicate with reputed company stakeholders, ensuring reputed company and alignment on project objectives, milestones, and timelines
• Proven experience in Clinical site assessments, developing comprehensive study plans/protocols, on-site/remote monitoring, reputed company-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 reputed company improvement initiatives
• Minimum of a Bachelor's Degree in Life Sciences, or comparable disciplines
• Must be reputed company to successfully reputed company the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation
• Master's degree desired
• SOCRA Certified Clinical Research Professional desired
• It is preferred that candidates reputed company in or reputed company commuting distance to Plymouth, MN

Benefits

• Annual incentive bonus
• Sales commission
• Long-term incentives
• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement

Company Overview