Clinical Research Specialist

Summit Orthopedics•Woodbury, MN

5d•Onsite

About The Position

At Summit Orthopedics, we recognize the significance each member of the Summit Family has as they impact one another and our patients on a daily basis. Be part of a patient-first environment that lives into our values of: Compassion, Integrity, Excellence, Collaboration, Stewardship and Innovation and a place where staff members feel respected and find a strong sense of purpose in their roles, contributing to a familial atmosphere characterized by mutual respect and enjoyment. The Clinical Research Specialist is responsible for coordinating and managing clinical trials, ensuring compliance with regulations, and supporting the physicians who are conducting research studies. This is a full-time position based at our corporate office in Woodbury with the expectation of traveling to other sites as needed for research. Scheduled is Monday-Friday, 8:00am to 4:30pm. Must be flexible to float to other Summit locations as needed.

Responsibilities

Design and Management: Will play a crucial role in designing, conducting, and managing clinical research programs. Will work closely with research teams to develop comprehensive research plans and ensure that all regulatory requirements are met.
Data Management: They are responsible for the accurate documentation and tracking of all data collected during clinical trials. This includes reviewing data for accuracy and consistency, managing the informed consent process, and monitoring study progress. Will work with both the Quality department (or other data input areas/departments) and with the physicians and clinical teams to ensure data is reflected accurately and produced into reports or documents that meet needs of all involved.
Collaboration: Clinical Research Specialists collaborate with physicians conducting research, regulatory and compliance areas, and clinical sites to ensure smooth site activation and compliance with research protocols. Attending Department, Service Line or Research meetings. Precepting research interns.
Research: Literature searches to determine novelty of proposed studies. Writing manuscripts for publication in scientific or medical journals. Has experience in preparing, submitting and managing Institutional Review Board (IRB) applications, amendments, continuing reviews and regulatory correspondence.
Perform other duties as assigned.