Senior Clinical Research Associate

Job Title: Senior Clinical Research Associate Location: Miami/Ft. Lauderdale, FL Type: Contract Compensation: $115,000 - $145,000 Work Model: Remote Hours: 40.0 hours/week

Overview

We are looking for a Senior Clinical Research Associate (CRA) to support end-to-end site management from initiation through closeout, ensure data quality, subject protection, and compliance with ICH-GCP and regulatory requirements. This is a remote/home-based role requiring regional travel (up to ~70%) for onsite monitoring. The candidate should be based out of the Miami/Ft. Lauderdale, FL area.

Responsibilities

• Provide site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout.
• Ensure collection of high quality data, timely adverse event reporting, subject protection and compliance to the protocol.
• Adherence to ICH-GCP, regulatory requirements, local ethics requirements, Company SOPs, and Clinical Development Guidelines.
• Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met.
• Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones.
• Trains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filing.
• Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.
• Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines.
• Completes system training (IMPACT, IV/WRS, EDC, CATS, CONCUR etc.) in order to adhere to protocol and SOP timelines to meet required deliverables.
• Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team.
• Identify potential risks and proactively take action to prevent or mitigate.
• Participates in Sponsor and Regulatory audits; preparing external trial staff and site records, addressing questions from Auditor, supporting external trial staff during audit, preparing audit responses ensuring compliance to local guidelines, Company SOPs and ICH-GCP.
• Adheres to Company policies, procedures ,vision and fundamentals.
• Acts as back up to the other monitors during absences, as requested.
• Performs other tasks as assigned by management.

Requirements

• Educational requirement: BA/BS.
• Years of experience: 4+ years of CRA (monitoring experience) - Ideally looking for folks with 5 years of field CRA experience.
• Industry experience: 6+ years of clinical research industry experience.
• Obesity experience is highly preferred.
• Remote Monitoring Experience.
• Risk Based Monitoring experience is a plus.
• Up to 70% travel required.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#LI- Ref: #568-Clinical