Job Description
Job Responsibilities:
- Manage & coordinate in-house clinical ops
- Act as site manager and company interface for active studies
- Responsible for site regulatory document collection, filing of study documents in trial master file (TMF), ICF review/approval, IRB/EC submission (including annual submissions), payments tracking, study supply management (as appropriate), study communication, field training and support
- Responsible for implementation of clinical study documents as needed, including but not limited to: ICFs, amendments to study protocols, SOPs, Work Instructions (WIs) and study-specific forms, to ensure appropriate compliance with site start-up and initiation process and applicable regulations
- Review sample, investigator-prepared and IRB-approved informed consents
- Support the design, format and content of study guides and subject instructions
- Coordinate activities associated with site startup
- Interface with in-house data and EDC/CTMS management to ensure seamless study execution
- Support clinical dossier preparation for CEC meetings
- Support prep of clinical sites for regulatory inspections
- Partner with and work cross-functionally with various team members
Job Requirements:
- 4+ years prior experience in clinical ops role – experience in Med Device or Spine industry strongly preferred
- Ability to travel for monitoring or as requested by the study team
- Strong project management skills with an entrepreneurial attitude
- Proficient with clinical trial management software including EDC, eTMF, CTMS
- Prior experience with IDE clinical trial and international regulatory process required including FDA; ICH and ISO:14155.
- Strong communication & problem-solving skills
- Self-motivated, team player, with excellent time management skills