Preston Tongo

• Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.

• Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.

• Responsible for multiple projects and must work both independently and in a team environment.

• Verifies that the investigator is enrolling only eligible subjects.

• Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.

• Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.

• Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.

• Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.

• Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.

• Delivers high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.

• Provides mentorship, training and direction to Clinical Research Associates when needed.

• Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.

• Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.

• Verifies the rights and well-being of trial subjects are protected.

• Reconciles site regulatory binder assuring collection and completeness of regulatory documents.

• Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out

• Identified, evaluated and established trial sites, and closing sites down on completion of trial.

• Trained site staff on the protocol requirements, proper source documentation and case report form completion.

• Ordered, tracked, and managed trial materials.

• Conducted regular site visits, coordinate project meetings and write visit reports.

• Implemented action plans for sites not meeting expectations.

• Managed and submitted IRB documentation.

• Ensured compliance with SOPs and local regulations, and ICH and GCP guidelines.

• Ensured the smooth running of the clinical trials.

• Supported operational aspects of clinical trials, including contract and budget negotiation, evaluation of the site, completed site qualification and initiation visits.

• Assisted with the development of study materials (including, but not limited to training slides, Monitoring Plans, Communication Plans, Safety Data Handling Plans, Informed Consent Forms and study binders).

• Organized, reviewed, and submitted IRB/EC applications.

• Prepared and maintained Trial Master Files (including study files, country files, site files and subject binders).

• Implement and monitor clinical trial to ensure investigator obligations are met and are compliant with protocol, FDA and ICH guidelines.

• Independently prepare and perform Investigator site visits relevant to the phase of the study: (Qualification, initiation, regular monitoring and site closure) as specified in the Project Plan and the Monitoring Guidelines.

• Ensure compliance of the trial conduct with the protocol and the applicable guidelines and regulations (FDA CFR21 / ICH-GCP).

• Ensured Site's source documents were compliant with the ALCOA Principles.

• Write/review patient documents (informed consent, subject information sheet), clinical study protocol, CRF and trial related financial agreements.

• Identify site issues and initiates correction plans based on monitoring reports.

• Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH - GCP guidelines, Standard Operating Procedures (SOPs), and sponsor requirements.

• Verify data in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner.

• Assures timely reporting of protocol violations as well as Adverse Events (AE)/ and or Serious Adverse Events (SAE)

• Verify drug accountability logs and storage requirements.

• Supported the day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements.

• Performed general administrative tasks to support project management activities related to the clinical trial execution, e.g., assisted with the development and formatting of documents, review, and reconciliation of study-specific information, etc.

• Assisted with document collection, dissemination, tracking and filling as per the organizational process ensuring compliance with SOPs and processes, and all applicable regulations.

• Assisted with the development and distribution of site binders as requested

• Tracked and prepared study-specific information utilizing databases, spreadsheets, and other tools as assigned. This included clinical and non-clinical supplies and services such as tracking of appropriate subjects and site activity/metrics, performing quality check activities across different components of the clinical trial.

• Set-up and coordinated meetings, took and distributed meeting minutes.

• Proactively identified and escalated issues that arose related to support of functional deliverables.

• Worked closely with study team members and study manger in order to fulfill assigned study execution tasks.

• Supported study material development as assigned