Clinical Research Intern (Summer)
About The Position
This position is responsible for supporting the Clinical and Post-Market Surveillance (PMS) teams by assisting with department responsibilities. Your duties will include: 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. Duties, responsibilities and activities may change at any time with or without notice.
Requirements
- 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.
- Must be enrolled in or graduated from a four-year science / engineering / technical undergraduate program.
Responsibilities
- Assist in drafting Periodic Safety Update Reports by compiling safety and performance data gathered through post-market surveillance activities.
- Prepare cover pages, executive summaries, and device descriptions for PSURs.
- Update and maintain Post-Market Surveillance plans and standard operating procedures (SOPs).
- Support the alignment of PSUR content with other technical documentation, such as Clinical Evaluation Reports (CER), and Summaries of Safety and Clinical Performance (SSCP).
- Maintain Trial Master Files (TMF) and essential documentation, ensuring adherence to Good Clinical Practice (GCP) standards.
- Assist requestors and coordinators in executing post-market clinical follow-up (PMCF) activities for established products.
- Assist with quality review and document review for clinical trials or observational follow-up studies.
- Conduct systematic searches of scientific literature and public databases to identify new safety information.
- Assist with published literature centralization project.
- Assist other departments as needed.
Benefits
- Competitive base salary
- Wellness opportunities
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What This Job Offers
Career Level
Intern
Education Level
High school or GED
