Project Clinical Research

Aboko Ernest Ajibogwu

**** ******** ** ******, ** 75254

423-***-**** ********@*****.***

Profile

A dedicated CRA with extensive knowledge of GCP, FDA and the pharmaceutical industry whose goal is to ensure the safety of humans, five (5) years of experience as a Clinical Research Associate I, II and III Clinical Trials

Therapeutic area includes: CNS, Cardiovascular, Ophthalmology, and Oncology

Ability to travel up to 80% nationwide.

Ability to work independently and in a team.

Confidently shown Leadership in several aspects in the Clinical industry.

Ability to perform SWAT PSSVs, SIVs, IMVs and COVs.

Good understanding and knowledge of ICH/GCP regulations and guidelines.

Strong analytic skills and good verbal writing skills

Proficient knowledge of the clinical trial process

Ability to manage time effectively and communicate across all levels.

THERAPEUTIC AREA OF EXPERIENCE

Cardiovascular -- Heart attack, Hypertension (Phase III)

Oncology – Solid Tumors- Gallbladder cancer, Esophageal cancer (Phase I)

Central Nervous System -- Bipolar disorder, Depression (Phase II-III)

Ophthalmology -- Glaucoma (Phase II- III)

Professional Experience

Parexel International, Atlanta GA

Clinical Research Associate III January 2014 – Present

Support and maintains an “organizational culture” of Quality within the organization.

Collaborates with Study Management Team to drive successful execution of domestic and global clinical trials from early phase to late stage and post-market studies.

Managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring relevant SOPs are met.

Providing input into and/or developing study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms, data completions guidelines, protocols, and patient informed consent.

Communicating directly with study site staff, tracking patient recruitment, study progress and timelines.

Support and document safety reporting, maintaining and reporting metrics for clinical site performance.

Track and study all available metrics on progress, finances, and obstacles to make recommendations to meet timelines.

Develops and maintains communication and collaborative working relationships with clinical investigative sites.

Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems as necessary.

Facilitates team meetings, including preparing minutes and agendas.

Participates with CROs and provides support to sites to prepare for clinical audits and to respond to audit findings conducting by internal QA/Regulatory.

Assists and/or leads efforts in protocol feasibility analysis, country assessment, site identification and patient recruitment and planning.

Independently performs centralized monitoring/remote monitoring. Conducts on-site monitoring visits (domestic and internationally), including site qualification, study site initiation, routine monitoring, and study site closure visits.

Coordinating the negotiation of site budgets within guidelines, and providing oversight for site payments per contracts.

Managing study-related vendors and serving as the primary point of contact for the contracted CROs, and study staff; identifying potential risks and resolving issues with CROs; establishing vendor management plans and reviewing quality metrics.

Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered, coordinating with CROs on site selection, IRB submissions, site initiation and close-out planning.

Cubist Pharmaceuticals, Lexington MA

Clinical Research Associate I and II Jan 2012- Dec 2013

Conducted clinical monitoring visits, (ie, pre-study, initiation, interim and close-out) which included all preparatory and follow-up aspects with a range of travel at 50-75% (approximately 10 days per month, e.g. for assigned site visits, investigator meetings, co-monitoring)

Trip report reviewed

Attended weekly sponsor/project management teleconferences

Was Involved in an initial review of study documents

Monitored site performance and compliance and provided management with necessary reports, updates, and recommendations

Prepared clinical sites for regulatory agency audits

Assisted in sites and data management with data query resolution

Actively participate in local Study Delivery Team meetings.

Contribute to the selection of potential investigators.

Train, support and advise Investigators and site staff in study related matters.

Contribute to national Investigators meetings.

Initiate, monitor and close study sites in compliance with AZ Procedural Documents.

Share information on patient recruitment and study site progress within local Study Delivery Team

Drive performance at the sites. Proactively identify study-related issues and escalate as appropriate

Update any Global systems with data from centers as per required timelines.

Manage study supplies, drug supplies and perform drug accountability at study sites, as applicable.

Perform source data verification per SDV plan.

Ensure data query resolution.

Ensure accurate and timely reporting of Serious Adverse Events.

Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.

Provide the required monitoring visit reports within required timelines.

Work with data management to ensure quality of the study data.

Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment).

Cubist Pharmaceuticals, Lexington MA

Clinical Trail Assocciate Jan 2011- Dec 2011

Assisted with conduct of site feasibility and associated tracking.

Coordinates the distribution and collection of site start up packets and essential documents. Tracks appropriately.

Communicated project status and provides associated reports to the project team as appropriate.

Assisted in the retrieval and resolution of issues with transmittals.

Scanned and copied project documentation inclusive of, but not limited to, essential documents, CSAs, CRFs, and DCFs.

Copied, collated and produced study binders.

Reviews deliverable to ensure accuracy of content and materials copied.

Supported the project team in preparation of documentation for Regulatory and Ethical Submissions.

Organized study documents and materials in compliance with Project and/or Sponsor SOPs as appropriate.

Archives study documentation and works with IT to return the TMF to sponsor, as directed.

Reported all document collection and tracking issues to SMS Team Lead and/or project team on a regular basis

Established the Trial Master File / eTMF in accordance with project, organizational and regulatory requirements.

Maintained the Trial Master File / e TMF as required by the study plans

Filed according to Company’s SOPs and/or Sponsor requirements along with Company quality standards and adhere to 98% accuracy across the major files sections and the documents contained therein.

Forwarded correspondence to sites, sponsors and project teams as needed.

Procured, stored, and shipped study supplies.

Interfaced with vendors as required for a project.

Participated in internal and external team meetings, provided updates as required, provided support to the team communicating process improvement suggestions as applicable.

Resolved administrative issues on behalf of the Project Manager.

Professionally represents Company in external meetings and regulatory inspections / audits.

Reviewed and maintained study Outlook folders.

Maintained project server and portal where applicable

Proactively identified, managed, escalated (as needed) and resolved site issues effectively and independently

Assisted with final site TMF review and Close Out Visit reconciliation packets. Communicate findings and provide packs to CRAs.

Qualification and training

Lee University, Cleveland, TN (Fall 2010)

Bachelor of Science, Accounting and /Minor- business Management

CTA/Intern Vanderbilt university medical center

Additional Skills

Microsoft Office 2016 (Outlook, Word, Excel, MS Project, Publisher, and PowerPoint) IWRS Languages &

IVRS Applications EDC Applications CTMS Applications

Languages & Proficiency: English.

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