Obinna Abalihi Email & Phone Number

Watertown, Massachusetts, United States

Cambridge, Massachusetts, United States

● Provide logistical support in the planning, execution, and management of clinical trials in accordance with ICH GCP and applicable regulatory requirements and SOPs, including the following:○ Develop study specific documents, plans, and tools (e.g. protocol, ICFs, manuals, etc.)○ Support vendor selection and oversight activities (e.g. tracking and reviewing documents)○ Aid in the planning and organizing of study-specific meetings and write and distribute regular updates○ Collect, track, and circulate large amounts of documentation accurately and within project timelines○ Organize and maintain essential documents and aid in the procurement of files for the TMF○ Distribute IMP and other study related supplies as needed○ Assist in managing timelines and deliverables with outside clinical support partners○ Maintain study-related trackers that support ClinOps and individual studies○ Proofread and perform quality control on official study documents○ Coordinate with regulatory and QA on implementation of SOPs

Boston, Massachusetts, United States

Perform critical day-to-day clinical study activities including:Organize tracking systems and tools to support clinical trial conduct from study start-up to close-outMaintain TMF and patient binders and ensure audit-readiness Draft study documents according to GCP regulatory requirements and study protocol Create regulatory submissions and interface with IRBs to obtain initial and amendment approvalsResponsible for updating, maintaining, and quality control of eTMF and shared file locationsSchedule and coordinate study meetings, materials, and agendas; record and disseminate decisions and actionsAttend monitor visits and complete all outstanding follow-up items in a timely mannerLiaise with sponsors, CROs, and external vendors to ensure clinical trial deliverables are met, such as documents, processes, set-up activities, etc. Conduct all AE/SAE reporting and data entry as well as answer queriesTrack and manage inventories of clinical trial supplies Created coding instructions for our investigator-led research program and oversee a group of research assistants responsible for data entry

Greater Boston Area

Bachelor'S Degree, Biopsychology

Education record