Remote Clinical Research Associate II | WFH

Job Overview

Join our mission-driven organization, dedicated to revolutionizing surgical treatment for bunions. As a Clinical Research Associate II, you will be instrumental in supervising clinical trial operations at investigational sites, ensuring adherence to Good Clinical Practices (GCP) and regulatory compliance. Your contributions will not only enhance patient outcomes but also support the continuous improvement of healthcare solutions.

Key Responsibilities

• Ensure strict compliance with study protocols, GCPs, Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee requirements by providing training and guidance to study investigators and coordinators.
• Act as the principal liaison between clinical sites and our organization, fostering communication and collaboration.
• Execute remote and in-person site qualification, start-up activities, initiation visits, monitoring for data integrity, and close-out visits while generating high-quality reports.
• Assist in the creation of protocols, informed consent documents, case report forms (CRFs), study plans, and reports for regulatory submissions.
• Safeguard the rights and welfare of human subjects by ensuring site compliance and reviewing adverse events, implementing necessary corrective measures.
• Maintain and update departmental Standard Operating Procedures (SOPs) and work instructions.
• Manage investigational device traceability, overseeing documentation for the forecasting, shipping, receiving, and disposition of devices.
• Document all clinical research activities meticulously in the trial master file (TMF), encompassing monitoring reports, site correspondence, and device inventory.
• Propel trial enrollment initiatives and proactively address challenges to recruitment efforts.

Required Skills

• Comprehensive understanding of Good Clinical Practices (GCPs), FDA regulations, and IRB standards.
• Strong project management capabilities with exceptional attention to detail and a commitment to delivering high-quality outcomes.
• Excellent professionalism and advanced communication skills, adept at engaging with various organizational levels and external partners.
• Proficient in Microsoft Office Suite and experienced with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
• Familiarity with clinical environments and experience collaborating with clinical staff.
• Knowledgeable in medical and anatomical terminology.
• Willingness to travel as needed.

Qualifications

• Minimum of 5 years of relevant experience in clinical research, with a focus on medical device trials and orthopedics.
• SUCRA/ACRP certification preferred.
• Bachelor’s degree in a science or related field is preferred.
• Travel requirement: Approximately 50%.

Career Growth Opportunities

We are committed to fostering an environment where our employees can thrive and grow professionally. By aligning with our objectives to enhance patient care, you will have opportunities to develop your expertise in clinical research and advance your career within a dynamic field.

Company Culture And Values

We uphold the highest ethical standards and are dedicated to exceeding our customers’ expectations through innovative solutions. Our commitment to a rewarding workplace experience extends not only to our employees but also to all stakeholders. We actively promote a culture of respect, inclusivity, and professional growth.

Compensation And Benefits

• Competitive salary commensurate with experience
• Comprehensive health, dental, and vision insurance
• Retirement savings plan
• Generous vacation and paid time off policy
• Opportunities for ongoing professional development.

Employment Type: Full-Time