Clinical Trial Assistant

Axogen • Tampa, FL

16h • Onsite

About The Position

The Clinical Trial Assistant is primarily responsible for administering Axogen’s clinical systems, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities.

Requirements

• Bachelor’s degree in a medical, scientific, engineering, or computer systems discipline or a commensurate combination of training and experience
• Prior experience with industry sponsored clinical research is strongly preferred
• A strong working knowledge of Good Clinical Practices governing human subject testing is strongly preferred
• Strong critical thinking and discretionary decision-making skills
• Strong organizational and time-management skills
• Ability to multi-task and prioritize autonomously in a fast-paced environment
• Excellent written & oral communication skills

Responsibilities

• Configuring study specific applications within Axogen’s Clinical Trial Management System (CTMS)
• Scanning, uploading, and assigning metadata for legacy documents needing to be migrated into eTMF
• Setting-up study specific Trial Master Files
• Performing Quality Control (QC) reviews of essential study documents and Trial Master Files to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices
• Processing essential documents and ensuring they are correctly filed in the appropriate Trial Master File
• Tracking and reporting TMF health metrics
• Tracking and reporting study metrics; inclusive of start-up, data management, and contracting as needed
• Participating in GxP audits and related clinical compliance
• Interfacing with study personnel (as needed) to ensure compliance with the study protocol, applicable regulations, and Good Clinical Practices
• Track, process, and organize various study supplies and shipments
• Under direct guidance, assist with coordination of basic study activities
• Preparing and tracking essential study documents (contracts, budgets, IRB documentation)
• Assisting with information gathering, literature searches, and creation of presentations as needed
• Maintain databases/spreadsheets as necessary to facilitate tracking/documentation of departmental activities
• Assist with vendor management and associated logistics, as assigned
• Assist in creating and implementing departmental
• Other projects and duties as required/assigned

Benefits

• Health
• Dental
• Vision
• Matching 401K
• Paid Time Off
• 9 Paid Holidays + 3 Floating Holidays
• Dependent Care Flexible Spending Accounts
• Medical Flexible Spending Accounts
• Tuition Reimbursement
• Paid Parental Leave
• Paid Caregiver Leave
• Basic Life Insurance
• Supplemental Life Insurance
• Employee Stock Purchase Plan
• Disability Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level