RedBrick Staffing
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr