Fabrice Walang, BS, MS

513-***-****- adye3x@r.postjobfree.com- Cincinnati Metro, Ohio

Clinical Research Training March 2017

ICH/GCP Training

University of Buea, Cameroon December 2016

Master of Science in Biochemistry,

University of Buea, Cameroon December 2014

Bachelor of Science in Biochemistry

Professional Summary

Experience, clinical research professional, with a broad understanding of the multidisciplinary functions contributing to the overall quality, completeness, and accuracy of scientific data in Neurology, CNS, Cardiovascular/Vascular Diseases, Endocrinology, Infectious Diseases, Dermatology, and Respiratory from Phase I-IV. Oversee and monitor activities of assigned study sites, throughout the study, to ensure a high-quality execution of clinical studies, safety, adherence, and compliance to designated protocol, FDA regulations, Good Clinical Practice (GCP) guidelines, policies, and sponsor (SOPs). Strong understanding of IDE clinical studies involving neurosurgical and cardiovascular medical devices with extensive monitoring and site training experience working with major academic medical centers across the U.S.

AREAS OF EXPERTISE

Onsite & Remote Monitoring Drug and Medical Device Trials Risk-Based Monitoring Clinical Trial Regulatory Project Management Protocol Development

Worldwide Clinical Trials

Sr. Clinical Research Associate: Contract (Home-Based, Cincinnati)

January 2022—Current

Complete Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and complete reports to quality standards within company specified timelines

Responsible for all tasks related to the monitoring and management of clinical trials for assigned sites

Monitor Phase I-IV clinical trials, assuring adherence to Good Clinical Practices

Prepares, collaborates and implements Corrective Action Plans with investigative sites

Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and Worldwide SOPs

Attends Investigator Meetings and study-specific training for assigned trials

Collaborates with the Lead CRA(s) to obtain/share trial specific issues across all study sites concentrating on areas related to quality, site performance and metrics

Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and CRAs as appropriate

Complete follow up letters for all visit types according to SOPs and complete reports to quality standards within company specified timelines

Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites

Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites

Performs on-site drug accountability and reconciliation

Verify drug storage and ensure that drug handling meets protocol and SOP requirements

Responsible for maintaining current Investigator Site File (ISF) in accordance with Worldwide SOPs

Performs ongoing reviews of ISF to assure quality of the documentation files and compliance with Worldwide SOPs, GCP and ICH Guidelines while on site

Responsible for assuring adequate and appropriate dissemination of information according to the study specific communication plan between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan

Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites

Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation.

Trials: Phase II, III and IV. Infectious Disease (HIV, Hepatitis C), Respiratory (Cystic Fibrosis), Cardiovascular (Hypertension), Pain Management (Headache Migraine, Rheumatoid Arthritis) Neurology (Intracerebral hemorrhage, Intercranial Hemorrhage, Stroke)

Number of site, 14. Regional Travel. Up to 75 percent travel

ProTrials Research, Inc.

Clinical Research Associate II: Permanent (Home-Based, Cincinnati)

October 2018—December 2021

Perform and coordinate all aspects of the clinical monitoring process in compliance with ICH/GCP guidelines and other regulatory agency guidelines

Conducted on-site monitoring visits at investigator sites, including SQV, SIV, IMV, COV.

Conduct site visits to determine protocol and regulatory compliance and prepare required documentation. Ensure that the data reported in site source documents is accurate, complete and verifiable

Perform drug accountability at site visits to ensure proper preparation, handling, dosing and storage of drugs

Review investigational trial files to ensure completeness and retrieve documents as appropriate for the sponsor’s trial master file

Maintain ongoing and continuous professional communication with the clinical site and the study team throughout the duration of the study

Assist with site selection as directed by team members

Assist with creation and modification of monitoring, reports documents, study specific monitoring plan and monitoring tools.

Document all study-related communication with the investigator and site staff in a suitable format and a timely manner, including telephone calls, web meetings, and face-to-face meetings

Ensured that site protocol deviations/violations and Serious Adverse Events (SAE) are appropriately prepared, tracked, documented, and reported to the sponsor and IRB according to the study-specific plan

Trials: Phase II-III Pain Management (Pain – Chronic Pain, Back, Rheumatoid Arthritis), CNS (Epilepsy, Bipolar disorder) Cardiology/Vascular Diseases (Coronary Artery Disease, Acute Limb Ischemia

Number of sites, 10. Nationwide travel. Up to 75 percent travel

University of Cincinnati Medical Center

Clinical Research Coordinator

June 2017— October 2018

Overseeing the smooth running of clinical trials.

Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.

Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).

Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.

Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.

Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

Registers participants to the appropriate coordinating center (if multi-site study).

Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.

Collects data as required by the protocol. Assures timely completion of Case Report Forms.

Maintains study timelines.

Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and Investigational Drug

Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

Retains all study records in accordance with sponsor requirements and university policies and procedures.

Maintains effective and ongoing communication with sponsor, research participants and PI during the study.

Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.

Works with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management.

Reporting

Technical Skills

MS Office-Word, Excel, PowerPoint, Project, Skype for Business, and Outlook. CTMS (Veeva, Impact Harmony, E-Clinical) EDC (IBM Clinical, Veeva EDC, Medidata RAVE, InForm, TrailMaster file), Electronic Trail Master (Veeva-Vault Clincal), Image Management System (AG Mednet) Amber Health, IVRS (ClinPhone)

Languages

French (fluent)

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