OBICHUKWU C. ILOANOFE

Aurora, IL *****, USA.

Phone: 773-***-****, Email: mailto:ad3oqr@r.postjobfree.com

CLINICAL RESEARCH PROFESSIONAL:

Dynamic, highly motivated, analytic, and detailed-oriented clinical research professional with over 13 years’ experience working within the Pharmaceutical, CRO, Medical device, and Biopharmaceutical industry, and years of experience in study management, site management, vendor management, data acquisition and

analysis of clinical trials phases I-IV in multiple therapeutic areas to ensure that clinical trials are conducted, recorded, and reported in accordance with protocol, clinical investigational plan, Good Clinical Practice (GCP) guidelines, International Conference on Harmonization (ICH) principles and guidelines,, policies and procedures, sponsor’s standard operating procedures (SOP), FDA regulations and other applicable regulations, while ensuring that subject safety and well-being, and integrity of clinical data are protected and are accurate.

SUMMARY OF PROFESSIONAL SKILLS:

International Conference on Harmonization Guidelines (ICH).

Good Clinical Practice Guidelines (GCP).

FDA Regulations.

Writing Reports.

Drug and or device Accountability.

Source Document Review (SDR) and Source Document Verification (SDV).

Regulatory Binder/ Essential Document/ Investigator Site File/ Trial Master File Review.

Strong command of medical and clinical terminology.

Strong verbal and written communication skills, outstanding interpersonal skills, problem solving skills, strong ability to engage in continuous learning and self-development, multi-task, fast learner, team player and can also work independently, dedicated, resourceful and goal driven individual with a positively flexible, adaptable and organized personality.

TECHNICAL EXPERTISE: MS Office-Word, Excel, PowerPoint, Project and Outlook. CTMS (Impact Harmony, E-clinical). EDC (Medidata Rave, Inform), EMR, IxRS.

THERAPEUTIC EXPERIENCE:

Oncology - Indication: Breast Cancer, Lung Cancer, Skin Cancer (Solid Tumors)

Respiratory

Endocrinology

Cardiology

Infectious Disease

Medical Devices

Dermatology, CNS

EMPLOYMENT HISTORY/EXPERIENCE

Associate Project Manager

HeartcoR Solutions LLC, Schaumburg, IL

July,2022 to Present

Associate Clinical Project Manager (APM) is key to the success of the overall conduct of a clinical trial from planning to final report. APM will assist in all areas of conducting a clinical research program and maybe responsible for the conduct of specific aspects of a clinical program including but not limited to: developing the clinical trial strategy, timelines, forecasting, managing the overall study budget, developing risk management / contingency plans for minimizing impact on project objectives, site selection and management, monitoring, coordination of clinical data management, data analysis functions, and CRO and Vendor selection and management.

Job Details:

Support the development of project related deliverables including the project management plan, overall clinical budget, study timeline, risk management / contingency plan, monitoring plan, communication plan, etc.

Responsible for developing study related documents, including protocol, informed consent, IB, regulatory binder, training materials, etc. and provide input to case report forms.

Responsible for managing and tracking overall study budget, payments, and provides financial updates.

Responsible for the proactive management and conduct of clinical trials. Provide centralized site support, communication and coordination to assure timely completion of start-up, enrollment and all other study activities.

Assist in the review site visit reports and enrollment progress and monitors the study for protocol, federal, and local compliance.

Support vendor selection process, including RFP to contract and change order process for CROs and other external service providers (ESP). Provide day to day management of ESPs ensuring quality deliverables and adherence to the scope of work.

Manage clinical supply shipments and inventory.

Ensure compliance with policy, procedures and SOPs, GCP, and local, regional and federal regulations.

Provide periodic updates, reports, etc. as requested. Manage ongoing communication of operation issues and provides progress reports to the study team.

Assist with Database freeze, Database lock, annual progress reports, and final clinical study reports.

Responsible for Site Management and Monitoring as required.

Other duties and responsibilities as assigned.

Study Management Associate (Remote)

AbbVie Pharmaceutical Inc Waukegan, IL

Feb 3,2021- May,2022

The Study Management Associate is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The SMA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.

Responsibilities:

Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).

Supports the Study Project Manager in leading the cross functional study team.

Supports the preparation of Clinical Study Team meetings (Agenda/Minutes).

Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date.

Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR).

Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie's processes and procedures and the applicable regulations.

Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies.

Proactively identify and resolve and/or escalate study related issues.

Participates in process improvement initiatives.

Assist with Site Management and Monitoring as required

Lead/Senior Clinical Research Associate (Remote)

Terumo Medical Corporation Somerset, NJ

July 2019- Jan 2021

Support the investigator evaluation and recruitment process:

oCreate phone scripts, questionnaires, and other assessment tools for use in the selection of sites.

oAssist team in the development of site recruitment and retention strategy.

oInitiate contact with PIs, conduct pre-visits, assess potential investigators and recommend suitability of the site.

Assist clinical team with study start-up activities:

oAssist in development of protocol / ICF / CRF / CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools.

oRequests and collects initial regulatory documentation.

oEnsure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval.

oPerforms study tracking and advises PM when an investigational site is approved and ready to receive investigational device and supplies.

Site Management and study execution activities:

oPlan and conduct training / site initiation, interim and close-out visits. Complete timely and accurate trip reports.

oAssess and monitor investigational device availability, making sure it is appropriately used, handled correctly, stored, and accurately inventoried and documented.

oFollow up with the site regarding timely completion and retrieval of CRFs and data correction forms.

oAssist sites to resolve regulatory document issues. Ensure adequate study and

oregulatory documentation is maintained at both the investigator site and the company.

oVerify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment.

oDocument and report non-compliance in a timely manner. Identify areas requiring follow-up and improvement at each clinical site, recommend corrective action and or conduct site re-training as needed.

oCommunicate findings from contact reports and monitoring visits to CRA Mgr and PM in a timely manner.

oReview site visit reports from field CRAs, perform patient profiling, and draft NTFs to close out any observation in preparation of sites for FDA/BIMO inspection.

oAssist Project Manager in Database freeze, Database lock, annual progress reports and final clinical study reports.

oPerform other clinical duties when requested.

CLINICAL RESEARCH ASSOCIATE II (Remote)

StatKing Clinical Services, Fairfield, OH

December 2014– July, 2019

Prepare for and conduct on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure the accuracy of collected data and that study requirements are being fulfilled and complete appropriate documentation (confirmation, follow-up letters, trip reports or communication logs) as required.

Perform monitoring and site management activities for clinical trials, clinical investigations, and other interventional studies to ensure that the rights and well-being of human subjects are protected, and the reported study data are accurate, complete, and verifiable from source documents, and assesses investigational product through physical inventory and record review.

Documents observations in reports and letters in a timely manner using approved report format.

Escalates observed deficiencies and issues expeditiously to the clinical management, and present potential solutions and follow all issues through to resolution.

Participates in site start up activities as assigned.

Supervises Screening & enrollment at assigned clinical sites.

Manages the completion and tracking of assigned project specific deliverables (milestones, timelines, and budgets).

Participates in site close-out activities for assigned clinical sites.

Maintains regular contact with investigative sites to ensure that the protocol is being followed, previously identified issues are being resolved and that data is being recorded in a timely manner.

Partner with colleagues to ensure assigned sites are audit ready at all times.

Conduct monitoring tasks in accordance with the approved monitoring plan.

Ensures adherence to study protocol, timeline and budget by evaluating overall performance of assigned site and staff.

Tracks and supervises collection of ongoing study data for the purpose of regular project status reporting.

Ensures study systems are updated per agreed study conventions (CTMS).

Collects and reviews regulatory documents as required by ICH GCP, and local regulations before, during and after a clinical trial.

Facilitates effective communication between investigative sites, the client and project team through written, oral and / or electronic contacts.

Coordinate the interactions with vendors to ensure that supplies to sites are sent in a timely manner and that samples are processed in a timely fashion.

Ensure that the sites adhere to appropriate reporting and documentation of adverse events, protocol deviations and subject enrollment as stipulated.

Reconciliation ISF versus TMF content, site management activity and collaboration with clinical project management to achieve recruitment goals and other site related goals and timelines, such as interim analysis or database cleaning.

eTMF tracker reconciliation to ensure QC of all essential documents updated in the TMF that includes proper filing and proper naming convention, all duplicates.

Serve as point of contact for vendors, investigational sites and cross functional teams.

Participate in Investigator’s meeting of assigned studies as assigned by Project Manager.

Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff.

Provide assistance to the Clinical Project Manager with the design of study materials, documents and processes.

Develop/ review Clinical Monitoring Plans for the assigned studies, presentations and project study-related documents. Support in the development and design of CRFs, including participating in the EDC specification process and User Acceptance test (UAT).

Act as the main liaison between the sponsor and study site by maintaining contact with the sites via telephone calls and emails between site visits and by responding to site concerns and questions.

Responsible for mentoring and oversight of junior team members, newly hired, and site staff through staff training and co-monitoring.

Escalate quality issues to Clinical Project Manager (CPM) or line manager.

CLINICAL RESEARCH ASSOCIATE I

Pfizer Inc formerly NextWave Pharmaceuticals Inc

October 2012 – November 2014

Conducted site pre-qualification/pre-trial assessment visits to determine sites suitability for the clinical study.

Conducted site initiation visits to train the site personnel on the proper conduct of the clinical study, ICH GCPs, protocol and ensured that all clinical supplies and study drugs had arrived at the site on time for the study to kickoff.

Conducted interim monitoring visits to ensure that the clinical study was conducted in compliance with the protocol, ICH GCPs, guidelines and other applicable regulations.

Conducted closeout visits to ensure that all clinical supplies and study drugs were returned to the sponsor and that IRB was informed about the study closure.

Established and maintained an open line of communication with site personnel.

Reviewed all documented Informed Consent Forms (ICF) for the subjects participating in the study to ensure that their rights, safety and well-being are protected.

Reviewed and verified all Case Report Forms (CRF) against the source documents to ensure accuracy and consistency of clinical data during of site visits.

Conduct contract negotiation with sites on study budget and facilitate legal review.

Complete appropriate therapeutic protocol and clinical research training to perform job duties.

Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.

Assisted, supported in the development and reviewed of a variety of documents including protocol, CRF, informed consent form and other related study documents.

Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Ensured that the assigned investigators and sites are in compliance with the study drug protocol, ICH GCP guidelines, and overall clinical objectives through evaluated and analyzed clinical data.

Maintained Trial Master File (TMF) and ensured that the CTMS is up-to-date and accurate.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letter, essential document collection and filing and other required study documentation.

Ensured proper documentation and timely reporting of AE, SAE, Concomitant Medications, Inter-Current illnesses and provided adequate follow-up as required.

Develop and maintain study trackers and reports, support and assist in the resolution of quality or audit findings.

Served as the main or central point of contact and site monitor for the assigned sites to ease resolution of issues as they surface, monitor the progress of projects and initiates necessary actions to achieve target objectives, and ensured that the study is conducted in compliance with the protocol, SOP, ICH GCP guidelines, and other applicable regulations.

Wrote high quality reports (visit and expense), confirmation, and follow up letters for every completed visit and follow up with the site to resolve pending issues from visits with sense of urgency.

Participate in site audit as requested.

Worked together with the internal work groups to evaluate needs, resources, and timelines.

CLINICAL RESEARCH ASSISTANT/DOCUMENTATION SPECIALIST

Nextwave Pharmaceuticals Inc., Cupertino, CA

June 2010 – September 2012

Receive track and inventory documents for central files. Ensure that documents required by team members are accessible. Obtain any missing/incomplete data from investigators in conjunction with CRAs.

Ensure accuracy of coded documents for central files, perform document scanning when applicable.

Produce reliable up to date reports of patient/study status through maintaining CTMS or client equivalent to ensure that clinical data input is up to date, accurate and complete.

Ensure the complete documentation and timely arrival of clinical supplies and study drugs for site visits, in conjunction with CRAs.

Ensure CRF pages are processed, tracked and forwarded to Data Management on time.

Assist with (telephone) query resolution as needed.

Ensure timely and accurate investigator payments, in conjunction with CRAs.

Participate in project meetings (taking minutes if appropriate); replace CRAs on project team calls when necessary.

Have up to date knowledge on study procedures and study related materials.

Serve as a resource for the project team or Clinical team, depending on workload can be delegated to other project related tasks (e.g. set-up activities, other).

Responsible for completeness, quality, and accessibility of Central Files.

Supervise receipt, tracking, and archiving of documents for Central Files.

Responsible for accuracy of coded documents for central files.

Responsible for up-to-date reports of study status in CTMS or client equivalent.

Responsible for the timely arrival of clinical supplies and study drugs at the sites.

Organize project meetings and take minutes.

Ensure the smooth operation of the department and departmental activities e.g., supervising arrangement of meetings and travel.

Proactively flag any project related issues.

ASSISTANCE PROJECT MANAGER

Neb Retail LLC, Baton Rouge, LA

January 2009–May 2010

Define the scope of the project in collaboration with senior management.

Create a detailed work plan which identifies and sequences the activities needed to successfully complete the project.

Determine the resources required to complete the project.

Develop a schedule for project completion that effectively allocates the resources to the activities.

Execute the project according to the project plan.

Develop forms and records to document project activities.

Set up files to ensure that all project information is appropriately documented and secured.

Monitor the progress of the project and make adjustments as necessary to ensure the successful completion of the project.

Review the quality of the work completed with the project team on a regular basis to ensure that it meets the project standards.

Write reports on the project for management and funder.

Monitor and approve all budgeted project expenditures.

Ensure that all financial records for the project are up to date.

Manage all project funds according to established accounting policies and procedures.

Prepare financial reports and supporting documentation for funders as outlined in the funding agreements.

PROJECT SUPERVISOR

Enplans Group Nig Limited, Enugu Nigeria

July 2006–December, 2008

Responsible for preliminary design cost estimate from the design professional submittal.

Reviewed the design schedule to ensure compliance with contracts and owners’ scope of work.

Prepared schedule of values for scheduled activities.

In charge of schedule monitoring and updates for effective time management.

EDUCATION & Certificates

Enugu State University of Science and Technology, Nigeria (ESUT). 2006

B.Sc. Agricultural Engineering (second class lower division

Comprehensive Monitoring for Medical Devices

Barnett International

Monitoring Visit Reports for Medical Device Studies

Barnett International

Training

OSHA 30hr General Training.

Health, Safety and Environmental Training.

Good Clinical Practice Training.

Onsite Clinical Research Monitoring Training (3weeks).

36 hrs Project Management Training.

Certifications

Certified Associate Project Management Professional (CAPM)

Project Management Institute (PMI)

Certified Construction Manager (CCM)

Construction Manager Certification Institute (CMCI)

Certified Clinical Research Professional (CCRP)

Society Of Clinical Research Associates (SOCRA)

Project Management Professional (PMP) Pending Dec. 2023

Project Management Institute (PMI)

Certified Medical Device Associate (CMDA) Pending March. 2024

World Medical Device Organization (WMDO)

Professional Conferences

Vascular Interventional Advances (VIVA) Conference, 2019 (Las Vegas, Nevada)

Vascular and Endovascular Issues Techniques and Horizon (VEITH) Conference, 2019 (New York, New York)

Vascular Interventional Advances (VIVA) Conference, 2020 (Virtual due to COVID-19)

FDA Clinical Trial Requirements, Regulations, Compliance, and GCP, 2020 (Virtual due to COVID-19)

REFERENCES

Available on Request

Contact this candidate