Mohamed (Mo) Aki, PhD, MBA, MSc, ACRP-CP, BCMAS

Harrisburg, PA Phone: 717-***-**** Email: adxzi6@r.postjobfree.com

linkedin.com/in/mohamed-akl-bcmas

Senior Clinical Research Associate

Accomplished clinical research professional with more than 12 years of scientific research and seven years of clinical research in oncology, immunology, hematology, vaccine, and gene therapy. Possesses demonstrated ability to develop and manage collaborative relationships with key opinion leaders (KOLs), principal investigators (PIs), healthcare professionals (HCPs), and research scientists to achieve research and project goals. Excels at presenting complex scientific and clinical information to varied audiences, including at high-profile meetings and conferences. Background includes Phase I, II, and III oncology, hematology, vaccine, and gene therapy clinical trials, scientific research, and initiating global collaborations.

Strengths & Expertise

KOL Relationships

HCP & PI Relationships

Global Oncology Clinical Trials

Scientific Research

Attending Investigator Meetings

ICH / FDA Guidelines

Publications & Presentations

Cross-functional Relationships

Strong Business Acumen

Oncology / Hematology

Immunology/ Vaccine/ Gene Therapy

Training & Mentoring

Professional Experience

ThermoFischer Scientific, Harrisburg, PA 2021 – Present

(Contract) Senior Clinical Research Associate I

Worked on 3 industry-sponsored phases II/III randomized, double-blind, open-label, Dose-Escalation, Age De-escalation, Observer-Blind, Placebo-Controlled, multi-arm, multicenter, Safety, Tolerability, and Reactogenicity, and Effectiveness of Vaccine (SARS-CoV-2), Oncology (Breast Cancer), and Gene Therapy (Glycogen Storage Disease) clinical trials in adult and pediatric subjects.

Perform clinical study site management/monitoring activities in compliance with ICH GCP, local laws and regulations, the protocol, the site monitoring plan, and associated documents

Act as the primary site contact and site manager throughout all phases of a clinical research study

Take overall responsibility for allocated sites

Participate in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems

Develop strong site relationships and ensure continuity of site relationships through all phases of the trial

Gain an in-depth comprehension of the study protocol and related procedures

Coordinate and manage various tasks in partnership with other roles to achieve Site Ready status

Participate in and provide input on site selection and validation activities

Perform remote and on-site monitoring and oversight activities using various tools to ensure that data generated at the site is complete, accurate, and unbiased and that the rights, safety, and well-being of subjects are protected

Conduct site visits, including but not limited to validation visits, initiation visits, monitoring visits, and close-out visits, and record clear, comprehensive, and accurate visit and non-visit contact reports in a timely manner

Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out

Communicate with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance

Perform root cause analysis and implement preventative and corrective action

Manage and maintain information and documentation in various systems per timelines

Support and/or lead audit/inspection activities

Identify, assess, and resolve site performance, quality, or compliance problems and escalate per defined escalation pathway in partnership with the team

Mentor Junior Clinical Research Associates on process/study requirements and perform co-monitoring visits

PRA Health Sciences (ICON), Harrisburg, PA 2020 – 2021

Senior Clinical Research Associate

Worked on 3 industry-sponsored phase III randomized, double-blind, multicenter, placebo-controlled, 2 arm, efficacy, and safety Oncology (Pancreatic Cancer) and Rare/Genetic Diseases/Disorders (AL Amyloidosis) clinical trials in adult subjects.

Performed site initiation, interim monitoring, and close-out visits in strict adherence to protocol, GCPs, ICH, and FDA guidelines.

Developed and managed relationships with study investigators to optimize relationships to identify and recruit study subjects.

Educated the investigators and site staff on the protocol, trial eligibility criteria, and study procedures.

Evaluated potential study sites to assess the ability to identify and enroll eligible patients into the clinical trial.

Monitored study enrollment and collaborated with investigators on strategies to overcome subject enrollment challenges.

Served as the liaison between investigators and sponsor representatives.

Presented updates on studies to sponsor representatives.

Attended and participated in investigator meetings.

Served as a therapeutic expert and provided education and mentoring to junior CRAs and other internal and external staff.

Assessed IP accountability, dispensation, and compliance at the investigative sites.

Reviewed and verified the accuracy of clinical trial data collected, either onsite or remotely.

Performed source document verification and query resolution.

Facilitated audits and audit resolution.

Performed essential document site file reconciliation.

Provided leadership skills to assigned projects and within the Clinical Operations department.

Served as observation visit leader.

Syneos Health, Harrisburg, PA 2017 – 2020

Clinical Research Associate II (07/2018 – 10/2020)

Clinical Research Associate (01/2017 – 07/2018)

Worked on multiple industry-sponsored Hematology/Oncology and immunology phase I-III randomized, double-blind, open-label, active-controlled, multi-arm, multicenter, 3-part, first-in-human, pharmacokinetics placebo-controlled, safety, tolerability, and efficacy (Prostate Cancer, Systemic Mastocytosis, Anemia, Cervical Cancer, Non-Small Cell Lung Cancer, Chronic Lymphocytic Leukemia, Hodgkin’s Lymphoma, B-Cell Lymphoma, Solid Tumors, Squamous Cell Carcinoma of the Head and Neck) clinical trials in adult subjects.

Performed site qualification, site initiation, interim monitoring, and close-out visits for in strict adherence to protocol, GCPs, ICH, and FDA guidelines.

Collaborated with MSLs, Medical Monitor, and other Clinical Operations team members to provide study updates and resolve study-related challenges.

Cultivated trusted relationships with investigators to monitor study progress closely and ensure that recruitment goals and timelines were met.

Leveraged clinical expertise to conduct pharmacology/mechanism of action analysis to boost enrollment at sites.

Attended and participated in investigator meetings.

Served as liaison between study sites and sponsor representatives to resolve any study or site-related issues.

Verified issues or risks associated with blinded or randomized information related to IP.

Supported subject/patient recruitment, retention, and awareness strategies.

Used judgment and experience to evaluate the site’s overall performance and provided recommendations regarding site-specific actions.

Immediately communicated/escalated serious issues and developed action plans.

Ensured assigned sites and site team members were trained and compliant with applicable requirements.

Performed investigational product inventory, reconciliation, and reviewed storage and security.

Ensured the investigator/physician site was aware of the requirement of archiving essential documents per local guidelines and regulations.

Assessed factors that might affect subject/patient's safety and clinical data integrity at an investigator /physician site, such as protocol deviation/violations and pharmacovigilance issues.

Hackensack Meridian Health, Hackensack, NJ 2014 – 2016

Lead Research Scientist, Genomics and Biomarkers Program

Conducted precision / personalized medicine research to identify novel biomarkers for relapsed / recurrent Hodgkin’s Lymphoma.

Initiated strategic collaborations with KOLs in the field of oncology, nationally and globally, to expand the scope of research and achieve project goals.

Published and presented research data at major conferences and meetings.

Trained, mentored, and supervised project scientist team on research and in the laboratory.

School of Pharmacy, University of Louisiana at Monroe, Monroe, LA 2009 – 2014

Postdoctoral Fellow (2013 – 2014)

Teaching & Research Assistant (2009 – 2013)

Initiated and led NIH / NCI-funded research project on developing breast cancer antiproliferative agents and metastasis inhibitors as monotherapy or in combination.

Performed literature reviews and attended scientific and medical meetings to stay abreast of the most current practices in oncology research. Presented findings to Principal Investigator and research team.

Developed collaborative relationships with KOLs, scientific thought leaders, and other researchers to support research objectives.

Trained and mentored doctoral students in research and in the lab.

Published and presented research data at major conferences and meetings.

Education & Professional Development

Master of Business Administration (MBA), Health Sector Management – 2018 (GPA: 3.84/4.0)

Pennsylvania State University, Malvern, PA

Doctor of Philosophy (PhD) in Pharmacy-Cancer Pharmacology – 2013 (GPA: 3.88/4.0)

University of Louisiana at Monroe, Monroe, LA

Master of Science (MS) in Pharmaceutical Sciences – 2008 (GPA: 4.0/4.0)

Bachelor of Science (BS) in Pharmaceutical Sciences – 2004 (GPA: 3.94/4.0)

Mansoura University, Mansoura, Egypt

Certifications

PPD Vaccines Academy Certificate Program, 2021. A comprehensive global development program is designed to ensure that candidates reach a high level of understanding and performance within the vaccine’s therapeutic area; program content is provided in a blended learning format with questions built into the modules to ensure learner understanding. Modules include: Basic Immunology for Vaccines, COVID 19 Vaccines, Vaccines Types, General Vaccines, Vaccine Clinical Development, Trial Considerations for Vaccines, and an Operational Platform

Board Certified Medical Affairs Specialist (BCMAS), Accreditation Council for Medical Affairs (ACMA), 2019

ACRP Certified Professional (ACRP-CP), Association of Clinical Research Professionals, 2019

Health Sector Management Certificate, Pennsylvania State University, 2018

Professional Affiliations

Association of Clinical Research Professionals (ACRP), 2014 – Present

Medical Science Liaison Society (MSLS), 2018 – 2020

American Medical Writers Association (AMWA), 2016 – 2018

American Association of Cancer Research (AACR), 2011 – 2014

American Association of Pharmaceutical Scientists (AAPS), 2010 – 2014

ADDITIONAL RELEVANT EXPERIENCE

Scale/Patient Reported Outcome Measures

oShort Form Health 36 (SF-36 v.2),

oKC Cardiomyopathy Questionnaire (KCCQ),

oFunctional Assessment of Cancer Therapy – Gynecologic Oncology Group Neurotoxicity Scale (FACT-GOG NTX),

oEuropean Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30),

oEuropean Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)

Audit Experience

oSponsor on-site Site audit

Computer Experience

oMicrosoft Office, MS Teams, WebEx, Skype, Zoom, Google Docs, Google Drive, Dropbox, EndNote

oClinical Trial Management Systems: IMPACT CTMS/ Medidata CTMS/ PSO

oIVRS/IWRS/RTSM: ClinPhone IVRS/ Endpoint/ Bracket (Signant Health)

oEDC: Medidata RAVE/ InForm

oTMF: Veeva Vault eTMF/ Trial Interactive

oRisk-Based Monitoring: Medidata RAVE RBM

oData Analytics: Spreadsheets, Tableau

oReporting & Analysis: SharePoint

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