Danielly Tavares

Experience

• 

  InVentiv Health Clinical

  Jan 2008 - Jan 2017

  • Act as primary liaison with study site personnel.• Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.• Review completion of proper informed consent procedures. • Ensure accurate data reporting via review of site source documents and medical records.• Interpret data to identify protocol deviations and risks to subject safety/data integrity.• Perform investigational product accountability as per the protocol and Study Monitoring Plan.• Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.• Obtain, review, and process essential regulatory and administrative documents. • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.• Participate in the identification and selection of investigators and clinical sites.• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.• Provide clinical and technical support for project team as required.• Utilize knowledge and experience to suggest improvements and/or innovations; pursue on-going systems improvements.• Provide mentoring / training to less experienced staff. May perform Monitoring Evaluation or Quality Assessment Visits.• May interact with representatives of client affiliates as per project requirements. Exibir menos • FDA inspection on May and June 2013, no FDA form 483 was raised.• Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.• Review completion of proper informed consent procedures.• Ensure accurate data reporting via review of site source documents and medical records.• Interpret data to identify protocol deviations and risks to subject safety/data integrity.• Generate queries and manage resolutions with site personnel.• Perform investigational product accountability as per the protocol and Study Monitoring Plan.• Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.• Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.• Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required.• Act as primary liaison with study site personnel.• Enter data into tracking systems as required.• Participate in the identification and selection of investigators and clinical sites.• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required. Exibir menos • Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.• Review completion of proper informed consent procedures. • Ensure accurate data reporting via review of site source documents and medical records.• Interpret data to identify protocol deviations and risks to subject safety/data integrity.• Generate queries and manage resolutions with site personnel.• Perform investigational product accountability as per the protocol and Study Monitoring Plan.• Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.• Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.• Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. • Enter data into tracking systems as required.• Act as primary liaison with study site personnel.• Participate in the identification and selection of investigators and clinical sites.• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.• May interact with representatives of client affiliates as per project requirements.• Provide clinical and technical support for project team as required. Exibir menos

  • Sr CRA

    Jan 2014 - Jan 2017

  • CRA II

    Jan 2011 - Jan 2014

  • CRA I

    Jan 2008 - Jan 2011
• 

  Syneos Health Clinical Solutions

  Nov 2017 - Jan 2022

  - Allocate workload and site assignments within the clinical monitoring team.- Review monitoring reports within the timelines mandated by SOPs or monitoring plans- Ensure quality of the clinical monitoring deliverable within a project and maintain proper visibility of its progress by the use of tracking tools- Ensure efficient dissemination of information across the CRA team- Interact with the client and other functional departments related to clinical monitoring activities and deliverable- Ensure alignment of clinical activities to budget- Support development of study materials and present them at investigator or study launch meetings- Support the identification of out of scope activities including the completion of clinical monitoring aspects of change orders- Participate in business development proposals, defense meetings and proposal development- Act as project manager on regional studies with limited scope of work- Create and deliver project level CRA training such as clinical monitoring plan, clinical monitoring aids and annotated visit reports Exibir menos

  • Sr. Clinical Trial Manager (Global)

    Jan 2022 - Jan 2022

  • Sr. Clinical Trial Manager (Latam)

    Jan 2021 - Jan 2022

  • Clinical Operations Lead/Clinical Trial Manager (Latam)

    Nov 2017 - Jan 2021
• 

  Medpace

  Jan 2022 - now

  Project Coordinador’s Line Manager activities performed: review daily activities, Performance Review, approval and review of timesheets and work balance.

  • Line Manager Project Coordinator (PC)

    Jun 2023 - now

  • Sr. Clinical Trial Manager, Associate Director

    Jan 2022 - now