Bob Eji, Ms Email & Phone Number

Managed startup process for the sponsor including budgets and contracts, MRI approvals, cath lab staff trainings, device shipments andreturns, IRB communications and correspondences.• Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate projecttimelines• Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation.• Assisted sites in MRI approval prior to study initiation• Facilitated in site Startup activities including CTA,Budget/Negotiation and preparation of IRB submissions.• Monitored Cardiac medical device studies.• Assisted my sites in trouble shooting of the analyzers when needed and ensured study supplies/devices are shipped out in a timely manner.• Served as primary contact for assigned research sites.• Verified that the investigator, staff, and site facilities remain adequate throughout the trial period.• Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and closeout visits according to themonitoring plan.• Ensured research sites conduct studies according to protocol requirements and applicable regulations and guidelines.• Reconciled site regulatory binder assuring collection and completeness of regulatory documents.• Collected and ensures completeness of all essential regulatory documentation from sites from study start-up through closeout.• Verified that written informed consent was obtained before each subject’s in the trial.• Verifies that the investigator is enrolling only eligible subjects.• Performed verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.• Ensured that corrections are appropriately documented.• Performed Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.

Managed startup process for the sponsor including budgets and contracts, MRI approvals, cath lab staff trainings, device shipments andreturns, IRB communications and correspondences.• Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate projecttimelines• Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation.• Assisted sites in MRI approval prior to study initiation• Facilitated in site Startup activities including CTA,Budget/Negotiation and preparation of IRB submissions.• Monitored Cardiac medical device studies.• Assisted my sites in trouble shooting of the analyzers when needed and ensured study supplies/devices are shipped out in a timely manner.• Served as primary contact for assigned research sites.• Verified that the investigator, staff, and site facilities remain adequate throughout the trial period.• Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and closeout visits according to themonitoring plan.• Ensured research sites conduct studies according to protocol requirements and applicable regulations and guidelines.• Reconciled site regulatory binder assuring collection and completeness of regulatory documents.• Collected and ensures completeness of all essential regulatory documentation from sites from study start-up through closeout.• Verified that written informed consent was obtained before each subject’s in the trial.• Verifies that the investigator is enrolling only eligible subjects.• Performed verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.• Ensured that corrections are appropriately documented.• Performed Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.

• Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines• Served as primary contact for assigned research sites.• Verified that the investigator, staff, and site facilities remain adequate throughout the trial period.• Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and closeout visits according to the monitoring plan.• Ensured research sites conduct studies according to protocol requirements and applicable regulations and guidelines.• Reconciled site regulatory binder assuring collection and completeness of regulatory documents.• Collected and ensures completeness of all essential regulatory documentation from sites from study start-up through closeout.• Verified that written informed consent was obtained before each subject’s in the trial.• Verifies that the investigator is enrolling only eligible subjects.• Performed verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.• Ensured that corrections are appropriately documented.• Performed Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.• Ensured all types of adverse events are reported and tracked per regulatory requirements and the monitoring plan.• Ensured that sites have sufficient project specific supplies. • Managed and motivated sites to meet study goals.• Communicated deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and took appropriate action to prevent recurrence.• Delivered high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.• Participates in site audits, as requested.

• Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.• Implement and monitor clinical trial to ensure investigator obligations are met and are compliant with protocol, FDA and ICH• 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.• Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required; and ensures training is provided within a reasonable timeframe, is current and is documented appropriately.• 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 requirement.

• Monitored investigator sites (initially under close supervision from CRAs and SrCRAs) to ensure compliance with project SOPs, requiring overnight travel up to 50% of the time Generated study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports.• Selected specialists for support in clinical trials.• Conducted project feasibility assessments.• Resolved queries of CRF data with study site personnel.• Obtained, review for appropriateness, and process regulatory and administrative documents from investigator.• Prepared investigator sites for sponsor audits and assisting sites with resolution of audit findings.• Provided support to Investigators, Study Coordinators and other appropriate site personnel regarding study workflow, overcoming obstacles and general questions regarding study conduct.• Participate when required, in other areas of study management and staff training and contribute to continuous improvement and the review of systems and procedures as appropriate.• Establish a gauge of monitoring competence to inexperienced/less experienced colleagues.• Study and conduct Drug Accountability at every Interim Monitoring Visit

• Worked in a team in the setup, operation, and maintenance of research equipment/instruments.• Assisted in all site start up requirements as regards regulatory binders and maintained associate shadow binders.• Collaborated in the collection, processing compiling, and verifying research data, samples, and/or or specimens.• Worked with teams in the development and execution of clinical research studies and programs.• Involved in data entry from forms and documents into databases and other documents.• Collaborated with various teams to administer logistics and drug shipments and ensure optimal safety and maintain track of all management files and tools and participate in various meetings with clients and investigators.• Collaborated with site staff to monitor all data and make required travel arrangement.• Maintained records and logs of all clinical research programs and assisted in filing and preparing presentations in both media and graphic format.• Assisted with routine data verification and quality control, ensuring data integrity and consistency with prescribed protocol.• Provided general office management to keep operations running smoothly.• Provided assistance in examining alcohol and caffeine use as related to social and cognitive behaviors by screening and recruiting subjects in accordance with study protocols.

Master Of Science - Ms, Environmental Health

Pmp

Bachelor Of Science - Bs, Microbiology