Experience

Antiva Biosciences, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Operations Consultant

  • Aug 2023 - Present

  Phase II HPV Phase II HPV



Spruce Biosciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Clinical Research Associate

  • Oct 2022 - May 2023

  Rare Disease, CAH Phase II • Responsible for creation and review of study documents including protocols, amendments, case report forms, site procedure manuals, study plans, ICF and tracking tools • Management of vendors, clinical sites, and issue escalation • Conduct co-monitoring site visits with CRO CRAs • Responsible for the review of monitoring visit reports, tracking of review, and issue resolution • Responsible for the management of the ongoing filing of study documents to… Show more Rare Disease, CAH Phase II • Responsible for creation and review of study documents including protocols, amendments, case report forms, site procedure manuals, study plans, ICF and tracking tools • Management of vendors, clinical sites, and issue escalation • Conduct co-monitoring site visits with CRO CRAs • Responsible for the review of monitoring visit reports, tracking of review, and issue resolution • Responsible for the management of the ongoing filing of study documents to the TMF. • Support CTAs with TMF set-up, training, maintenance, and quality review • Present Clinical Operation updates at team meetings (Clinical Trial Team Meeting, Investigator Meeting) Show less Rare Disease, CAH Phase II • Responsible for creation and review of study documents including protocols, amendments, case report forms, site procedure manuals, study plans, ICF and tracking tools • Management of vendors, clinical sites, and issue escalation • Conduct co-monitoring site visits with CRO CRAs • Responsible for the review of monitoring visit reports, tracking of review, and issue resolution • Responsible for the management of the ongoing filing of study documents to… Show more Rare Disease, CAH Phase II • Responsible for creation and review of study documents including protocols, amendments, case report forms, site procedure manuals, study plans, ICF and tracking tools • Management of vendors, clinical sites, and issue escalation • Conduct co-monitoring site visits with CRO CRAs • Responsible for the review of monitoring visit reports, tracking of review, and issue resolution • Responsible for the management of the ongoing filing of study documents to the TMF. • Support CTAs with TMF set-up, training, maintenance, and quality review • Present Clinical Operation updates at team meetings (Clinical Trial Team Meeting, Investigator Meeting) Show less



Assembly Biosciences, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Research Associate

  • Oct 2021 - Oct 2022

  Viral Disease, HBV Phase I & II • Assists in the creation and review of study documents including protocols, amendments, case report forms, site procedure manuals, study plans, ICF and tracking tools • Assists with study start-up activities including vendor RFPs, vendor selection, feasibility, budget negotiations, site qualification, investigator selection, and site initiation. • Responsible for the review of monitoring visit reports, tracking of review, and issue resolution •… Show more Viral Disease, HBV Phase I & II • Assists in the creation and review of study documents including protocols, amendments, case report forms, site procedure manuals, study plans, ICF and tracking tools • Assists with study start-up activities including vendor RFPs, vendor selection, feasibility, budget negotiations, site qualification, investigator selection, and site initiation. • Responsible for the review of monitoring visit reports, tracking of review, and issue resolution • Responsible for sample management, tracking, and reconciliation • Assists in the management of the ongoing filing of study documents to the TMF. Responsible for performing periodic QC of assigned sections of the TMF. Provides TMF support & guidance for Clinical Trial Assistant. Reviews CRO TMF Plan. • Train and mentor on-boarding Clinical Trial Assistants.

• Senior Clinical Trial Associate

  • Jun 2020 - Oct 2021

  • Support the planning, conduct, management, and completion of assigned clinical trials under the leadership and guidance of the CTM/Sr. CTM • Cultivate and maintain excellent working relationships with study vendors, including Contract Research Organizations (CROs) • Assist in planning and organizing Investigator Meetings • Schedule the Study Management Team (SMT) and other vendor meetings and draft the SMT meeting agenda and minutes and update the action item/decision/issue… Show more • Support the planning, conduct, management, and completion of assigned clinical trials under the leadership and guidance of the CTM/Sr. CTM • Cultivate and maintain excellent working relationships with study vendors, including Contract Research Organizations (CROs) • Assist in planning and organizing Investigator Meetings • Schedule the Study Management Team (SMT) and other vendor meetings and draft the SMT meeting agenda and minutes and update the action item/decision/issue escalation log • Provide accurate and up-to-date information and study status reports to the clinical team members • Lead TMF QC Reviews



Aimmune Therapeutics

• United States
• Biotechnology
• 100 - 200 Employee

• Clinical Trial Associate

  • May 2017 - Jun 2020

  • Responsible for compiling/QC checking of clinical documents, TMF management • Implementation of TMF structure in preparation for eTMF conversion • Coordinates distribution and shipment of study-related materials • Provides administrative support to Clinical Operations team members • Facilitates flow and maintenance of correspondence with sites • Responsible for compiling/QC checking of clinical documents, TMF management • Implementation of TMF structure in preparation for eTMF conversion • Coordinates distribution and shipment of study-related materials • Provides administrative support to Clinical Operations team members • Facilitates flow and maintenance of correspondence with sites



BioMarin Pharmaceutical Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior TMF Coordinator

  • Jul 2015 - Apr 2017

  • Knowledgeable with Regulatory, Pre-clinical, BAS, and Clinical documentation and records management • Maintains an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records • Performs quality checks on both electronic and paper documents submitted to either the Records Room or the eTMF and verifies, tracks and QC’s the receipt of documents • Manage the TMF content list and TMF… Show more • Knowledgeable with Regulatory, Pre-clinical, BAS, and Clinical documentation and records management • Maintains an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records • Performs quality checks on both electronic and paper documents submitted to either the Records Room or the eTMF and verifies, tracks and QC’s the receipt of documents • Manage the TMF content list and TMF Comprehensive Review tracker. Participate in the development and implementation of internal databases to manage records • Management of records room, archiving of TMF/eTMF, participation in the management of vendor relationships including offsite storage. Prepares inventory, shipment and retrievals of records to/from offsite storage. • Responsible for orienting, training, and monitoring of new or temporary Records Management staff and customers to ensure established procedures are followed. • Familiar with a variety of records management databases, such as the Veeva Vault eTMF, Clinical Document Management Database, and LiveLink (via scan / index software). • Support the Records Management and the Study Team in TMF document retrieval during Audits and Inspections • Participant of RAC EU (Regulatory Affairs Certification) Study Group

• TMF Administrator

  • Jul 2015 - Nov 2015

  • Files, sorts, separates, photocopies, prints, scans, indexes, distributes labels and files a variety of clinical study records and documents in accordance with SOP mandated timelines. • Fulfills customer requests for retrieval, reproduction, and re-filing of records or their electronic images (e.g. pdf). Assists with other requests. • Enters new and updated records information accurately in a variety of records management databases • Manage calendar and scheduling, make event… Show more • Files, sorts, separates, photocopies, prints, scans, indexes, distributes labels and files a variety of clinical study records and documents in accordance with SOP mandated timelines. • Fulfills customer requests for retrieval, reproduction, and re-filing of records or their electronic images (e.g. pdf). Assists with other requests. • Enters new and updated records information accurately in a variety of records management databases • Manage calendar and scheduling, make event arrangements • Create meeting minutes and agendas, word processing, creating spreadsheets and presentations, and filing.