This is from the blog that govorchin referenced elsewhere. This lady worked for the CRO managing B-OM and this is her resume’. I posted this from that blog and highlighted what I thought was intriguing, namely that she assisted in5(3 filing of INDs for Brilacidin For Oral Mucositis. Compare that with what you posted. I pulled out the relevant quote but it’s in5(3 bottom paragraph.
“Assisted with compilation, preparation of & submission of IND for Oral Mucositis.”
Innovation Pharmaceuticals (formerly Cellceutix Corporation), Beverly, MA
Manager, Clinical Operations 2013-2014
Assisted with CTIX-BRI-204 Phase II ABSSSI Trial; 4 sites; 215 subjects; positive results
Manager, Clinical Operations 2014-2018
?Concept/Protocol to DBL (38 months); 18 sites; 61 randomized subjects (head & neck chemo/RT
patients); ~30.5% withdrawal rate; primary & secondary endpoints met (CSR still pending)
Managed the CTIX-BRI-205 Phase II Oral Rinse for Oral Mucositis Trial fromStudy Manager, responsible for oversight of operational study deliverables, and day-to- day study operations and administration.
Assisted with creation & presentations of materials for SIVs
Assisted with preparation and made input to Investigator Brochure, Clinical Protocols, Informed Consents, manuals and forms needed for clinical trials
Management of all vendors including those for clinical supplies for trials as well as hotel & travel vendors for potential investigator meetings; also reviewed & approved trial invoicing
Responsible for overall IRB submissions for oral mucositis study with central IRB
Made site visits as part of the team conducting SIVs, also made follow up visits to sites both trials)
Over-saw roll out of ClinTrialApp for Oral Mucositis study; responsible for updating documents & other information in app
Acted at TMF Process Owner assisting w/resourcing, unitization and oversight of the Trial Master File system; also supervised Clinical Trial Associates (TMF Specialists) responsible for TMF, maintenance & reorganization of Beverly locked file room
Organized, procured, stored and tracked expenditures of clinical supplies for Oral Mucositis trial
Oversaw consultant responsible for shipping clinical supplies
Worked with vendor responsible for packaging, storing & shipping drug product to keep sites supplied at all times
Assisted with preparation of electronic documents for FDA submissions (for several INDs & study serial submission) including fact checking, proofreading, reformatting, etc. utilizing MS Word and Adobe Acrobat.
Assist with compiling hybrid paper/electronic submissions to FDA including preparing desk copies (as needed) & shipping to FDA; also burned & tested CDs for submissions
Responsible creating and maintaining for all submission documents (1571, cover letters, etc.), preparation of submissions, shipping and filing of paper copies in Beverly
Assisted with compilation, preparation of & submission of IND for Oral Mucositis
Member of ABSSSI & OM Phase II study teams, attended team meetings, conference calls, etc.; responsible for purchase, storage & shipping of all clinical study supplies.
“Assisted with compilation, preparation of & submission of IND for Oral Mucositis.”
Innovation Pharmaceuticals (formerly Cellceutix Corporation), Beverly, MA
Manager, Clinical Operations 2013-2014
Assisted with CTIX-BRI-204 Phase II ABSSSI Trial; 4 sites; 215 subjects; positive results
Manager, Clinical Operations 2014-2018
?Concept/Protocol to DBL (38 months); 18 sites; 61 randomized subjects (head & neck chemo/RT
patients); ~30.5% withdrawal rate; primary & secondary endpoints met (CSR still pending)
Managed the CTIX-BRI-205 Phase II Oral Rinse for Oral Mucositis Trial fromStudy Manager, responsible for oversight of operational study deliverables, and day-to- day study operations and administration.
Assisted with creation & presentations of materials for SIVs
Assisted with preparation and made input to Investigator Brochure, Clinical Protocols, Informed Consents, manuals and forms needed for clinical trials
Management of all vendors including those for clinical supplies for trials as well as hotel & travel vendors for potential investigator meetings; also reviewed & approved trial invoicing
Responsible for overall IRB submissions for oral mucositis study with central IRB
Made site visits as part of the team conducting SIVs, also made follow up visits to sites both trials)
Over-saw roll out of ClinTrialApp for Oral Mucositis study; responsible for updating documents & other information in app
Acted at TMF Process Owner assisting w/resourcing, unitization and oversight of the Trial Master File system; also supervised Clinical Trial Associates (TMF Specialists) responsible for TMF, maintenance & reorganization of Beverly locked file room
Organized, procured, stored and tracked expenditures of clinical supplies for Oral Mucositis trial
Oversaw consultant responsible for shipping clinical supplies
Worked with vendor responsible for packaging, storing & shipping drug product to keep sites supplied at all times
Assisted with preparation of electronic documents for FDA submissions (for several INDs & study serial submission) including fact checking, proofreading, reformatting, etc. utilizing MS Word and Adobe Acrobat.
Assist with compiling hybrid paper/electronic submissions to FDA including preparing desk copies (as needed) & shipping to FDA; also burned & tested CDs for submissions
Responsible creating and maintaining for all submission documents (1571, cover letters, etc.), preparation of submissions, shipping and filing of paper copies in Beverly
Assisted with compilation, preparation of & submission of IND for Oral Mucositis
Member of ABSSSI & OM Phase II study teams, attended team meetings, conference calls, etc.; responsible for purchase, storage & shipping of all clinical study supplies.
