Job Summary Under supervision of the Regularoty Affairs Manager, the Regulatory Affairs Intern is responsible for administrative activities in support of ongoing, Zimmer Biomet clinical trials in the areas of hip, knees and extremities. This may include review and audit of in-house clinical study data, clinical study file documentation, logging tracking, and shipping of clinical trial documents and materials, filing clinical trials documentation including electronic scanning, electronic and hard-copy filing of clinical research documents, and drafting letters and e-mails to clinical study sites. May be involved in literature reviews to support post-market surveillance activities. Will work with clinical personnel on Product Experience Reporting by contacting clinical sites to obtain required information. Must be committed to corporate goals of patient safety, customer satisfaction, and continuous improvement.
Principal Duties and Responsibilities
-Supports study managers with clinical trial activities including but not limited to filing clinical trial documentation including scanning documents for electronic copies, filing hard copies in clinical study files, querying sites on discrepant data, maintaining listings for sites and external diagnostic partners, assisting with annual report development, preparing for investigator/coordinator meetings.
-Review of study files periodically for accuracy and completeness
-Assist in the management of external research projects including the preparation of new review packets, processing milestone payments and maintaining files.
-Assist study management personnel with Product Experience Reporting by contacting sites for information and working the post market surveillance team
-Conduct literature searches and review for protocol development, post market surveillance activities and product investigations.
-Compiles monthly journal article summaries for submission to marketing for iPAD application
Assists with review of discrepant data for all studies as needed
Expected Areas of Competence -Demonstrated analytical skills, organizational skills, and attention to detail. Ability to perform (or oversee) the complex analysis of large amounts of data. In-depth understanding of clinical data system and analytical report development from internal and external data sources.
-Intermediate knowledge of statistical principles.
-Excellent oral and written communication skills, including strong technical writing skills to collate and present the data to internal and external customers.
- Ability to communicate ideas and persuade others in order to accomplish objectives.
-Sets priorities consistent with company goals and focuses on high priority opportunities.
-Allocates resources (e.g. time, dollars) consistent with priorities.
-Knowledge of national and international standards related to Good Clinical Practices and ability to use sound judgment independently within assigned areas of responsibility.
-Demonstrates teamwork and encourages and supports information sharing and collaboration across departments.
Education/Experience Requirements -Must be actively enrolled an academic program for the entire duration of the assignment.
-Pursuit of Bachelor’s Degree in the health, life sciences, or engineering disciplines.
-Preference of current student in an advanced Master’s Program focusing on biostats, clinical research, quality systems or regulatory affairs.
-GPA of 3.2+ preferred
Additional Information EOE M/W/Vet/Dis