RedBrick Staffing
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
: 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