Dede Adi Email & Phone Number

Collaborated with cross-functional teams to develop and refine clinical trial protocols, ensuring alignment with study objectives.Prepared detailed trial plans, outlining milestones, timelines, and resource allocation.Managed site selection processes, evaluating and selected investigative sites with the potential to meet study requirements.Oversaw the preparation and submission of regulatory documents for ethics committee approvals and regulatory agency submissions.Conducted comprehensive site initiation visits, ensuring sites are adequately prepared for the trial.Managed the allocation of resources, including personnel, equipment, and materials, to support trial activities.Led and coordinated monitoring activities, including site visits, to ensure adherence to protocol, regulations, and quality standards.Collaborated with Clinical Research Associates (CRAs) to facilitate site performance, resolve issues, and ensure data accuracy.Implemented risk-based monitoring approaches, identifying and mitigating potential risks to trial success.Oversaw patient recruitment strategies and assisted sites in overcoming recruitment challenges.Ensured that the trial complies with regulatory requirements, ICH-GCP guidelines, and standard operating procedures (SOPs).Conducted site audits and inspections, monitoring compliance with study protocols and regulatory standards.Implemented quality assurance checks.Built and lead multidisciplinary trial teams, fostering collaboration, motivation, and a culture of excellence.Oversaw data collection, management, and analysis processes, ensuring data quality and integrity.Collaborated with data management teams to develop data collection tools and electronic data capture (EDC) systems.Prepared and reviewed clinical study reports, contributing to data-driven decisions and regulatory submissions.Ensured the safety and well-being of trial participants by implementing robust safety monitoring and reporting procedures.

Remote

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.Verifies required clinical data entered in the case report form (CRF) is accurate and completeApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labeled, imported and released/returned.Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

Remote

Prepare, conduct and report on activities related to the completion of site selection, initiation, routine monitoring and close-out visitsMonitor patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country levelPerform source data verification and follow up on data queries at the site level, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visitsEnsure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviationsAct as the main line of communication between the Sponsor and the siteBe a point of contact/liaison for in-house support services and vendorsEnsure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical study suppliesReview the status and contents of essential documents at the site level and reconcile study OSF/ TMF at site and/or country levelSupport the maintenance of the Investigator Site Files and Trial Master FilesConduct all aspects of site management as prescribed in the clinical trial specific functional plans.Prepare accurate and timely monitoring visit reportsReview progress of clinical trials, especially patient recruitment and clinical trial data capture and initiate appropriate actions to achieve objectives.

Houston, Texas, United States

Collaborated with CRA on site issues/actions. Created and distributed study document (e.g. Agreement, Amendments, etc.). Updated all relevant tracking systems on an ongoing basis. Maintained site staff details. Performed regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS) Conducted remote visits (initiation, monitoring, close-out). Collected updated/amended regulatory documents in collaboration with CRA and CTS as needed Reviewed recruitment plan and enrollment updates and addressed/resolved issues pending. Addressed protocol questions and checked on site staff assignments. Assessed drug/study supply status and requested outstanding documents. Followed-up on data entry, query status and SAEs. Maintained a working knowledge and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements and specific procedure (e.g., Monitoring Plan).

United States

Collaborated with CRA on site issues/actions. Updated all relevant tracking systems on an ongoing basis. Maintained site staff details. Performed regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, ISIS) Addressed protocol questions and checked on site staff assignments. Assessed drug/study supply status and requested outstanding documents. Followed-up on data entry, query status and SAEs. Handled high volume of incoming calls for appointment requests, directions and multiple inquiries.