Senior Clinical Research Associate

Job Title: Senior CRA
Location: Bethlehem, Pennsylvania
Type: Contract
Compensation: $65/hr
Work Model: Remote - US
Hours: Monday–Friday, 8:00 AM–5:00 PM, 1-hour lunch
Overview
The Senior Clinical Research Associate (Sr. CRA) is responsible for assisting with the execution of clinical studies by COMPANY. Responsibilities include coordinating, monitoring, and oversight of the clinical studies to ensure compliance with the protocol and SOPs, ICH GCP, and all applicable regulatory standards. The Sr. CRA will also participate as a member of cross-functional core teams, manage vendors, and supervise CRAs
Responsibilities

• Conduct and oversee clinical site monitoring activities.
• Perform site qualification, initiation, interim monitoring, and close-out visits.
• Review and develop clinical monitoring plans.
• Ensure study compliance with protocols, SOPs, ICH-GCP, FDA requirements, and applicable regulations.
• Prepare monitoring visit reports and follow-up documentation.
• Identify qualified investigators and support site selection.
• Provide investigator and site coordinator training.
• Support multiple clinical studies simultaneously.
• Manage site start-up activities, regulatory documentation, enrollment, and study close-out.
• Coordinate clinical study deliverables and timelines.
• Support site budgets and vendor coordination.
• Communicate study progress, challenges, and updates to management.
• Develop and review study protocols, informed consent forms, monitoring plans, clinical study reports, and data collection forms.
• Work with Electronic Data Capture (EDC) systems.
• Establish, maintain, and review Trial Master Files (TMF/eTMF).
• Review monitoring reports and clinical data for accuracy and completeness.
• Support database activities and clinical data review.
• Assist with regulatory submission documentation.
• Oversee CROs, clinical vendors, and laboratory vendors.
• Track study deliverables, budgets, and timelines.
• Coordinate with R&D, marketing, labeling, and other internal departments.
• Support regulatory inspections and audit readiness.
• Review and improve SOPs when necessary.

Requirements

• 4+ years CRA experience (5+ years preferred).
• Previous Sr. CRA experience (strong preference).
• Hands-on site monitoring (must have personally conducted monitoring visits).
• Monitoring plans (ability to review and execute monitoring plans).
• Multiple study management (strong multitasking and prioritization).
• EDC experience (clinical data systems).
• TMF/eTMF experience (documentation management and review).
• GCP / FDA regulations (clinical trial compliance).
• Bachelor's degree required (Science or nursing preferred; other fields considered with relevant experience).
• Strong verbal and written communication skills.
• AI tools / automation experience (must explain practical experience and use cases).
• Medical device / IVD studies experience (preferred).
• Usability experience (preferred).
• Vendor / CRO oversight experience (preferred).

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.

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Ref: #558-Scientific