Clinical Research Intern (Summer)

MicroPort Orthopedics•Lakeland, TN

About The Position

This position is responsible for supporting the Clinical and Post-Market Surveillance (PMS) teams by assisting with department responsibilities. The intern will 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. The role also involves updating and maintaining Post-Market Surveillance plans and standard operating procedures (SOPs), supporting the alignment of PSUR content with other technical documentation, and maintaining Trial Master Files (TMF) and essential documentation, ensuring adherence to Good Clinical Practice (GCP) standards. Additionally, the intern will assist in executing post-market clinical follow-up (PMCF) activities, quality review and document review for clinical trials or observational follow-up studies, conducting systematic searches of scientific literature and public databases, and assisting with published literature centralization projects. The intern may also assist other departments as needed. 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

Analytical thinking
Problem solving
Communication and interpersonal skills
Technical writing
Teamwork
Understanding of engineering and orthopedic terminology
Microsoft Office software proficiency
Ability to learn relevant software systems
Must be enrolled in or graduated from a four-year science / engineering / technical undergraduate program.

Nice To Haves

Bachelor’s Degree

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.