Clinical Associate

Overview

• Support clinical department in maintaining and managing clinical studies and associated documentation.
• Coordinate and oversee inventory management for clinical testing materials and supplies.
• Assist in scheduling, preparation, and packaging for clinical study operations.
• Maintain databases for clinical tracking and Trial Master File document management.
• Ensure compliance with standard operating procedures and quality management systems.
• Provide administrative support for scheduling meetings and coordinating clinical team events.
• Assist in tracking and preparation of study documents, including informed consent forms and protocols.
• Maintain clinicaltrials.gov entries and manage IRB submissions and approvals.

Key Responsibilities & Duties

• Coordinate ordering and shipping of supplies for clinical studies.
• Prepare and maintain traceability logs for investigational products used in studies.
• Manage Trial Master File documentation and ensure confidentiality.
• Assist in material preparation and shipment for clinical studies.
• Track and manage IRB submissions and approvals at sponsor and site levels.
• Prepare study documents, including protocols, monitoring plans, and case report forms.
• Support clinical team in scheduling and coordinating meetings and events.
• Ensure compliance with QMS processes for packaging and labeling clinical products.

Job Requirements

• Bachelor’s Degree in a life science or health-related discipline.
• Minimum of 4 years of experience in clinical or medical device industry.
• Proficiency in Microsoft Office Suite and familiarity with QMS systems.
• Strong organizational skills and attention to detail.
• Ability to work independently and collaboratively within a team setting.
• Experience with investigational product documentation and label printing software.
• Willingness to travel for job-related activities (