Benefits:

Dental insurance

Health insurance

Paid time off

Profit sharing

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

Publication experience (e.g. journals, etc.)

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