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.

• 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.

• 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.

• 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.
• 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.
• 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.

• 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.
• 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.

• 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.

Master Of Science - Ms, Environmental Health

Pmp

Bachelor Of Science - Bs, Microbiology