Clinical Research Intern (Summer)

Benefits

Qualifications

• •Competency skills include analytical thinking, problem solving, communication and interpersonal skills, technical writing, and teamwork
• •Technical skills include understanding engineering and orthopedic terminology, Microsoft Office software, and the ability to learn relevant software systems
• •Required: HS Diploma or GED - Must be enrolled in or graduated from a four-year science / engineering / technical undergraduate program
• •No related experience required
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Responsibilities

• •This position is responsible for supporting the Clinical and Post-Market Surveillance (PMS) teams by assisting with department responsibilities
• •PSUR Preparation Support: Assist in drafting Periodic Safety Update Reports by compiling safety and performance data gathered through post-market surveillance activities
• •This includes preparing cover pages, executive summaries, and device descriptions Documentation Maintenance: Help update and maintain Post-Market Surveillance plans, and standard operating procedures (SOPs)
• •Regulatory Alignment: Support the alignment of PSUR content with other technical documentation, such as Clinical Evaluation Reports (CER), and Summaries of Safety and Clinical Performance (SSCP)
• •Regulatory Documentation: Maintain Trial Master Files (TMF) and essential documentation, ensuring adherence to Good Clinical Practice (GCP) standards
• •Observational Study Support: Assist requestors and coordinators in executing post-market clinical follow-up (PMCF) activities for established products, such as femoral stems or other orthopedic devices
• •Data Management: Assist with quality review and document review for clinical trials or observational follow-up studies
• •Scientific Literature Review: Conduct systematic searches of scientific literature and public databases to identify new safety information
• •Article Library: assist with published literature centralization project Assist other departments as needed
• •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
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