At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary:
The Clinical Research Associate (CRA) is responsible for monitoring and supporting clinical study sites to ensure the rights, safety, and well-being of study participants and the integrity of clinical data. The CRA conducts site qualification, initiation, interim monitoring, and closeout activities in accordance with study protocols, applicable regulations, Good Clinical Practice (GCP), and company standard operating procedures (SOPs). The CRA serves as a primary liaison between the sponsor and investigational sites, providing guidance on protocol requirements, regulatory compliance, data collection, and study conduct. Responsibilities include reviewing study documentation, verifying source data, identifying and resolving site issues, and ensuring timely and accurate reporting of study data and adverse events. The CRA maintains current knowledge of clinical research regulations, industry standards, and therapeutic area developments. The position may contribute to the development and review of study-related materials, including informed consent forms, case report forms, source documents, site training materials, and monitoring plans. The CRA collaborates with cross-functional teams to support study objectives, maintain data quality, and ensure successful execution of clinical research projects.
Essential Functions:
- Conducts remote and on-site monitoring activities, including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits, in compliance with standard operating procedures and applicable regulatory requirements. Develops monitoring expertise through ongoing training and collaboration with senior clinical team members.
- Reviews source documentation, verifies study data, evaluates protocol compliance, and ensures timely identification, documentation, and escalation of study issues, including adverse events, protocol deviations, and corrective and preventive actions.
- Monitors site enrollment, retention, protocol compliance, and data quality metrics; identifies site performance issues and collaborates with investigators, site personnel, and study leadership to support timely resolution.
- Supports site compliance with study protocols, Good Clinical Practice (GCP), applicable regulations, company procedures, and sponsor requirements through routine monitoring, issue identification, and follow-up activities.
- Establishes and maintains productive working relationships with investigators, site personnel, sales representatives, and internal stakeholders to support study execution, evaluate site feasibility, and promote successful study outcomes.
- Supports the development, review, and maintenance of study documents for assigned studies, including clinical study protocols, case report forms and subject questionnaires, informed consent forms, electronic data capture (EDC) systems, and other study tools.
- Participates in process improvement initiatives and contributes feedback to support the enhancement of clinical operations procedures, tools, templates, and best practices.
- Contributes to a highly collaborative and solutions-oriented team culture by actively participating in study team meetings, sharing site-level updates and insights, and supporting cross-functional initiatives. Demonstrates a positive attitude, adaptability, and a willingness to contribute to departmental projects and organizational priorities as needed.
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to the role.
- Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
- Excellent verbal, written, and interpersonal communication skills, with a demonstrated ability to collaborate effectively across functions and contribute to a positive, team-oriented culture.
- Bachelor's degree in a scientific, healthcare, engineering, or related discipline; equivalent combination of education and relevant clinical research experience may be considered.
- Minimum of 1-3 years of experience in clinical research within the medical device, biotechnology, or pharmaceutical industry, including direct experience monitoring clinical studies.
- Working knowledge of clinical research principles, Good Clinical Practice (GCP), and applicable regulations governing clinical studies.
- Familiarity with FDA regulations, ISO 14155, EU MDR requirements, and/or other applicable clinical research regulations preferred.
- Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities, meet deadlines, and maintain attention to detail in a fast-paced environment.
- Proficiency with Microsoft Office applications; experience with electronic data capture (EDC), clinical trial management systems (CTMS), or other clinical research technologies preferred.
- Ability to travel up to 70% of the time
Physical Demands:
The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
