Dr. Haitham Abulaban MBBS,ACRP-PM, CCRC.

Director of Clinical Research at Axiom Clinical Research of Florida

Tampa, FL

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Work experience

Aug 2019 - Present

Axiom Clinical Research of Florida

Director of Clinical Research

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Jan 2015 - Present

University of South Florida

Therapeutic Experience:

Neurological Study FYN, a Phase 2a Multi-­‐Center Study of 18F-­‐FDG PET, Safety, and Tolerability of XXXXXX in Mild Alzheimer’s Disease A4 Study, multicenter, randomized, double-blind, placebo-controlled, Phase 3 study comparing 400 mg XXXXXX with placebo given as infusions once every 4 weeks over 3 years in approximately 1150 subjects with preclinical AD A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-XXXX (SCH XXXXX) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal AD).

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Jan 2015 - Aug 2019

University of South Florida

Clinical Research Administrator

Prepare Institutional Review Board submissions Facilitate the preparation of source worksheets and other standard work sheet Ensure regulatory documents completions Ensure adverse events are reported in a timely manner Ensure study documentation is completed in a timely manner and according to regulations Coordinate scheduling of research visits appointments Serve as primary advocate for the research participant Prepare study logs Obtain Informed Consent from Subjects Study and understand each study protocol Adhere to research protocol Accurate data collection per protocol requirement Taking ECG and vital signs Monitor subjects for adverse events Promptly report Serious Adverse Effects or any other safety issue to the IRB and the Sponsor Specimen collection, coagulation test, serum collection, and other study related procedures. Create and update Regulatory Document binder Create The Source Document Data Collection- accurate and complete Data Entry to eCRF Extract data from source document. Collate data from Case Report Forms. Query Resolution Packaging, Documenting, specimen and Scheduling a Pickup. Preparation of reports for Institutional Review Board Attend Investigator’s meetings Available to monitors and other site visitors Prepare Reports for Data and Safety Monitoring Board Drug dispensation and accountability Comply with GCP and other applicable regulatory requirements including ICH guidelines. Organize

Feb 2014 - Jan 2015

KG Clinical Research

Site Director

Facilitate protocol review with Principal Investigators and Study Coordinators Ensure continued awareness of Good Clinical Practices Liaise with study sponsor representatives Facilitate communication and decision making- within the research team Prepare Institutional Review Board submissions Create and negotiates study budget and site costs Develop and ensures compliance with standard operating procedures Develop recruitment and retention plans with research team Facilitate the preparation of source worksheets and other standard work sheet Ensure regulatory documents completions Network and build referral mechanism Ensure adverse events are reported in a timely manner Ensure study documentation is completed in a timely manner and according to regulations Coordinate scheduling of research visits appointments and research team meetings Serve as primary advocate for the research participant Prepare study logs Obtain Informed Consent from Subjects Study and understand each study protocol Adhere to research protocol Accurate data collection per protocol requirement Taking ECG and vital signs Monitor subjects for Hypoglycemia and other adverse events Promptly report Serious Adverse Effects or any other safety issue to the IRB and the Sponsor Specimen collection, coagulation test, serum collection, and other study related procedures. Create and update Regulatory Document binder Create The Source Document Data Collection- accurate and complete Data Entry to eCRF Extract data from source document. Collate data from Case Report Forms. Query Resolution Packaging, Documenting, specimen and Scheduling a Pickup. Preparation of reports for Institutional Review Board Attend Investigator’s meetings Available to monitors and other site visitors Prepare Reports for Data and Safety Monitoring Board Drug dispensation and accountability Comply with GCP and other applicable regulatory requirements including ICH guidelines. Organize

Jun 2012 - Oct 2013

Jedidiah Clinical Research

CRC

Obtain Informed Consent from Subjects Study and understand each study Protocol. Adhere to Research Protocol Accurate data collection per protocol requirement Taking ECG and vital signs Monitor subjects for Hypoglycemia and other adverse events Promptly report Serious Adverse Effects or any other safety issue to the IRB and the Sponsor Specimen collection, coagulation test, serum collection and other study related procedures. Create and update Regulatory Document binder Data Collection- accurate and complete Extract data from source document. Collate data from Case Report Forms. Query Resolution Packaging, Documenting, specimen and Scheduling a Pickup. Preparation of reports for Institutional Review Board Attend Investigator’s meetings Available to monitors and other site visitors Prepare Reports for Data and Safety Monitoring Board Drug dispensation and accountability Comply with GCP and other applicable regulatory requirements including ICH guidelines. Organized successful Social Mobilization activities, and Advocacy visits, aimed at recruiting patients for the trial and discourage traditional treatment with high fatality rates

Jun 2012 - Oct 2013

Jedidiah Clinical Research

Therapeutic Experience:

Dermatological Study A Multicenter, Double Blind, Randomized Vehicle Controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of XXXXX Topical Gel in Impetigo Ongoing Diabetic Study A Randomized, Parallel-Arm, Double Blinded Study Comparing the Effect of Once-Weekly XXXXX with Placebo in Patient with Type 2 Diabetes Mellitus on XXXX Therapy. Ongoing Diabetic Study Two Treatment Approaches for XXXXX (Thrice-Daily versus Twice-Daily) In Subjects with Type 2 Diabetes mellitus Not Achieving Adequate Glycemic Control on High-Dose XXXX Therapy w.ith Or without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial Ongoing Cardiovascular A Phase III, multicenter, international, randomized, parallel group, Double blind cardiovascular safety study of XXXX compared to usual care in type 2 Diabetes mellitus patients with increased cardiovascular risk Ongoing Insulin Basal Analog III A Comparison of XXXX versus XXXX as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: A Double- Blind, Randomized Study Ongoing Volunteer Attending morning report, Observing the patient with Supervisor Doctors, Filling reports. Elective Collecting Samples and Survey, Filling reports, Attending Surgeries.

Education

2005 - 2010

Liaquat University of Medical and Health Sciences

Bachelor of Medicine, Bachelor of Surgery (MBBS)

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