Ryan Chando Email & Phone Number

•Responsible for providing expertise in ethics and regulatory submissions, the collection and finalization of essential documents required for site initiation.•Responsible for Study Development including creation of project plans, overseeing system set-up, and development of project level documents.• Responsible for performing final QC of start-up documents prior to Site activation/ IP Release. •Oversee Internal eTMF Audits with tasks such as performing quality control reviews, completing study TMF inventories and resolving outstanding issues in a timely manner.

Raleigh-Durham, North Carolina Area

•Responsible for Study Development including creation of project plans, overseeing system set-up, and development of project level documents.•Participates in Quick start camps, Kick off Meetings, and Quality Finish Camps.•Subject Matter Expert (SME) as part of a Sponsor partnership spanning 20+ studies.•Responsible for 2nd review/approval of Study, Country & Site level ICF templates. •Member of the site activation QC team responsible for performing the final review of all start-up documents and providing approval for site activation/ IP Release. •Provided cross-function training for current and new team members.•Assisted with any SSU I & II activities listed below.

Raleigh-Durham, North Carolina Area

•Oversee additional Start-up Specialists to ensure activation milestones and projections are achieved and provide accurate and through updates to the project team and sponsor accordingly. •Responsible for providing expertise in ethics and regulatory submissions, the collection and finalization of essential documents required for site initiation.•Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.•Responsible for coordinating/leading internal and sponsor SSU meetings.•Previous Site Start-Up and Regulatory Specialist I activities listed below.

Raleigh-Durham, North Carolina Area

•Responsible for providing delivery and expertise in the following functional areas: ethics and regulatory submissions, creation of study required project plans, country ICF adaptation, and review and finalization of essential documents required for site initiation.•Act as the main Point of Contact for Sponsors and sites for all phase of clinical trials.•Maintained industry/company training compliance and metrics.•Maintained consistent ICH‐GCP, CFR, FDA, and CRO level industry compliance.

Raleigh-Durham, North Carolina Area

- Perform Trial Master File (TMF) system administrative duties within the document repository including: TMF builds, granting user access, making corrections or changes to the eTMF, and answering study documentation related questions- Mentor and train new team members on INC and client processes related to Trial Master File- Create and maintain the document repository for all study-related documents- Ensure security of documents at all times in accordance with relevant SOPs/WIs- Adhere to project-specific data tracking guidelines as well as relevant SOPs/WIs- Receive and inventory applicable project documents- Process, scan, index, route, and maintain files for CRFs, DCFs and data management documents in accordance with SOPs/WIs- Maintain the security and compliance of all documents related to ongoing projects as well as archive documents in accordance with relevant SOPs/WIs- Respond timely to requests for study documents pulling and re-filing study documents; ensure applicable paperwork is completed upon release from and return to the Document Control room- Participate in preparation/reconciliation of study documentation related to archival/shipping to sponsors- Participate in project specific training as required- Assist in overseeing filing and consistency of multiple studies across the program level- Assist in creation of department trainings-Participates in preparation and reconciliation of study documentation including archival and shipping to sponsors-Receives and inventories Trial Master File Documentation, Investigator File Documentation, and all other applicable project documents-Retrieve requested project files and re-file project files in an accurate and timely manner. Ensure all applicable paperwork is completed upon release and return of each project file from the Trial Master File.-Participates in project specific training as necessary

- Perform Trial Master File (TMF) system administrative duties within the document repository including: TMF builds, granting user access, making corrections or changes to the eTMF, and answering study documentation related questions- Mentor and train new team members on INC and client processes related to Trial Master File- Create and maintain the document repository for all study-related documents- Ensure security of documents at all times in accordance with relevant SOPs/WIs- Adhere to project-specific data tracking guidelines as well as relevant SOPs/WIs- Receive and inventory applicable project documents- Process, scan, index, route, and maintain files for CRFs, DCFs and data management documents in accordance with SOPs/WIs- Maintain the security and compliance of all documents related to ongoing projects as well as archive documents in accordance with relevant SOPs/WIs- Respond timely to requests for study documents pulling and re-filing study documents; ensure applicable paperwork is completed upon release from and return to the Document Control room- Participate in preparation/reconciliation of study documentation related to archival/shipping to sponsors- Participate in project specific training as required- Assist in overseeing filing and consistency of multiple studies across the program level- Assist in creation of department trainings-Participates in preparation and reconciliation of study documentation including archival and shipping to sponsors-Receives and inventories Trial Master File Documentation, Investigator File Documentation, and all other applicable project documents-Retrieve requested project files and re-file project files in an accurate and timely manner. Ensure all applicable paperwork is completed upon release and return of each project file from the Trial Master File.-Participates in project specific training as necessary

Business/Commerce, General

Associate Of Arts (Aa), Business Management

Activities and Societies: Deans List